Trial Outcomes & Findings for SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study (NCT NCT02439749)

NCT ID: NCT02439749

Last Updated: 2025-03-28

Results Overview

All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis \>70% (6 months for new renal artery stenosis)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 366 participants
• Primary outcome timeframe: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
• Results posted on: 2025-03-28

Participant Flow

Participant milestones

Measure	Renal Denervation Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Overall Study STARTED	182	184
Overall Study COMPLETED	153	147
Overall Study NOT COMPLETED	29	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Baseline characteristics by cohort

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.	Total n=366 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	158 Participants n=5 Participants	167 Participants n=7 Participants	325 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	17 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 10.8 • n=5 Participants	52.7 years STANDARD_DEVIATION 10.1 • n=7 Participants	52.6 years STANDARD_DEVIATION 10.45 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	56 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	128 Participants n=7 Participants	245 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	60 Participants n=7 Participants	116 Participants n=5 Participants
Race/Ethnicity, Customized Japanese from Japan	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	78 Participants n=5 Participants	87 Participants n=7 Participants	165 Participants n=5 Participants
Region of Enrollment Greece	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Austria	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	85 participants n=7 Participants	176 participants n=5 Participants
Region of Enrollment Japan	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Ireland	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Australia	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Germany	34 participants n=5 Participants	38 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)

All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis >70% (6 months for new renal artery stenosis)

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From baseline to 3 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.

Outcome measures

Measure	Renal Denervation n=153 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=147 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring	-4.5 mmHg Standard Deviation 10.8	-0.6 mmHg Standard Deviation 8.7

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Significant Embolic Event Resulting in End-organ Damage	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Renal artery perforation requiring intervention

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Renal Artery Perforation Requiring Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Number of Participants with Renal artery dissection requiring intervention

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Renal Artery Dissection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Vascular Complications	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

• Volume management refractory to diuretics
• Hyperkalemia unmanageable by diet and diuretics
• Acidosis bicarbonate <18 unmanageable with HCO3 supplements
• Symptoms of uremia, nausea, vomiting

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With End-stage Renal Disease	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

≥40% decline in eGFR

Outcome measures

Measure	Renal Denervation n=171 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=170 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Decline in eGFR	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Number of Participants with New myocardial infarction

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Myocardial Infarction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Number of Participants with New stroke

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
New Stroke	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Renal artery re-intervention

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Renal Artery Re-intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Major Bleeding According to TIMI Definition	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Increase in serum creatinine > 50% from screening visit 2.

Outcome measures

Measure	Renal Denervation n=171 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=170 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Increase in Serum Creatinine	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post-procedure

Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.

Outcome measures

Measure	Renal Denervation n=182 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 1 month post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=169 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Office Systolic Blood Pressure	-10.2 mmHg Standard Deviation 14.0	-5.7 mmHg Standard Deviation 11.8

SECONDARY outcome

Timeframe: From baseline to 1 month post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in office diastolic blood pressure from baseline (Screening Visit 2)

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=169 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Office Diastolic Blood Pressure	-5.3 mmHg Standard Deviation 8.3	-2.9 mmHg Standard Deviation 7.6

SECONDARY outcome

Timeframe: From baseline to 1 month post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=169 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants Achieving Target Office Systolic Blood Pressure	32 Participants	11 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=164 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure	-9.4 mmHg Standard Deviation 14.8	-2.3 mmHg Standard Deviation 12.7

SECONDARY outcome

Timeframe: From baseline to 3 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

All-cause mortality

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With All-cause Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

≥40% Decline in eGFR

Outcome measures

Measure	Renal Denervation n=165 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=149 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With ≥40% Decline in eGFR	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

• Volume management refractory to diuretics
• Hyperkalemia unmanageable by diet and diuretics
• Acidosis bicarbonate <18 unmanageable with HCO3 supplements
• Symptoms of uremia, nausea, vomiting

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With End-Stage Renal Disease (ESRD)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

New Myocardial Infarction

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With New Myocardial Infarction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Number of Participants with New Stroke

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
New Stroke	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Renal Artery Re-intervention

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Renal Artery Re-intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Major Bleeding According to TIMI Definition	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

Outcome measures

Measure	Renal Denervation n=165 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=149 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Increase in Serum Creatinine	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol

Outcome measures

Measure	Renal Denervation n=181 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Hospitalization for Hypertensive Crisis	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

Outcome measures

Measure	Renal Denervation n=153 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=147 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM	-3.5 mmHg Standard Deviation 6.7	-0.8 mmHg Standard Deviation 5.7

SECONDARY outcome

Timeframe: From baseline to 3 months post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=164 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Office Diastolic Blood Pressure	-5.0 mmHg Standard Deviation 8.3	-1.0 mmHg Standard Deviation 8.0

SECONDARY outcome

Timeframe: From baseline to 3 months post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

Outcome measures

Measure	Renal Denervation n=170 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=164 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants Achieving Target Office Systolic Blood Pressure	27 Participants	12 Participants

SECONDARY outcome

Timeframe: From baseline to 6 month post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Confirmed by angiography and as determined by the angiographic core laboratory.

Outcome measures

Measure	Renal Denervation n=163 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=125 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With New Renal Artery Stenosis > 70%	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 month post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Outcome measures

Measure	Renal Denervation n=127 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=39 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Systolic Blood Pressure as Measured by 24-hour ABPM	-16.2 mmHg Standard Deviation 14.6	-22.0 mmHg Standard Deviation 13.3

SECONDARY outcome

Timeframe: From baseline to 36 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in diastolic blood pressure as measured by 24-hour ABPM

Outcome measures

Measure	Renal Denervation n=127 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=39 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM	-11.7 mmHg Standard Deviation 9.6	-15.0 mmHg Standard Deviation 8.0

SECONDARY outcome

Timeframe: From baseline to 36 months post procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in Office Systiloc Blood Pressure From Baseline (Screening Visit 2) to 36 months.

Outcome measures

Measure	Renal Denervation n=154 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=47 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Office Systolic Blood Pressure	-21.9 mmHg Standard Deviation 15.5	-26.4 mmHg Standard Deviation 12.8

SECONDARY outcome

Timeframe: From baseline to 36 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Change in office diastolic blood pressure

Outcome measures

Measure	Renal Denervation n=154 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=47 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Change in Office Diastolic Blood Pressure	-10.8 mmHg Standard Deviation 10.4	-15.4 mmHg Standard Deviation 10.8

SECONDARY outcome

Timeframe: From baseline to 36 months post-procedure

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Outcome measures

Measure	Renal Denervation n=154 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=47 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg)	70 Participants	33 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post-randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With All-cause Mortality	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment are at study start.

Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

• Volume management refractory to diuretics
• Hyperkalemia unmanageable by diet and diuretics
• Acidosis bicarbonate <18 unmanageable with HCO3 supplements
• Symptoms of uremia, nausea, vomiting

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With End-Stage Renal Disease (ESRD)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

≥40% Decline in eGFR

Outcome measures

Measure	Renal Denervation n=144 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=40 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With ≥40% Decline in eGFR	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

New Myocardial Infarction

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With New Myocardial Infarction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

New Stroke

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With New Stroke	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Renal Artery Re-intervention

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Renal Artery Re-intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Major Bleeding According to TIMI Definition	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

Outcome measures

Measure	Renal Denervation n=144 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=40 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With an Increase in Serum Creatinine	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Confirmed by angiography and as determined by the angiographic core laboratory.

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With New Renal Artery Stenosis > 70%	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 36 months post randomization

Population: The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications orthe protocol

Outcome measures

Measure	Renal Denervation n=166 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=104 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Number of Participants With Hospitalization for Hypertensive Crisis	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 36 months post-procedure

Population: The number of participants analyzed reflects the number of subjects with prescribed medications reported.

Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.

There are no clinically established thresholds.

Outcome measures

Measure	Renal Denervation n=165 Participants Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=54 Participants Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Antihypertensive Medication Burden to 36-months	2.09 Medication Index 2 Score Standard Deviation 2.40	3.20 Medication Index 2 Score Standard Deviation 3.60

Adverse Events

Renal Denervation

Serious events: 38 serious events

Other events: 149 other events

Deaths: 1 deaths

Sham Procedure

Serious events: 36 serious events

Other events: 155 other events

Deaths: 2 deaths

Serious adverse events

Measure	Renal Denervation n=182 participants at risk Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 participants at risk Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Cardiac disorders Angina Pectoris	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Atrial Fibrillation	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Cardiac Arrest	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Cardiac Failure	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Gastritis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Abscess	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Appendicitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Covid-19	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Concussion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Ligament Rupture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Ankylosing Spondylitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Arthralgia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Back Pain	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Aphasia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Basal Ganglia Hemorrage	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Cerebrovascular Accident	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Dizziness	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Encephalopathy	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Abnormal Uterine Bleeding	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Deep Vein Thrombosis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Blood and lymphatic system disorders Mast Cell Activation Syndrome	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Blood and lymphatic system disorders Thrombotic Microangiopathy	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Coronary Artery Disease	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Superventricular Tachycardia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Ventricular Tachycardia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Faecaloma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Gastric Mucosal Lesion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Hepatobiliary disorders Cholecystitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Hepatobiliary disorders Cholelithiasis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Immune system disorders Anaphylactic Shock	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Covid-19 Pneumonia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Endocarditis Bacterial	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Influenza	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Localized Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Otitis Externa	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Pyelonephritis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Pyelonephritis Acute	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Sepsis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Non-Cardiac Chest Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Colitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Pyrexia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Subcutaneous Abscess	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Systemic Candida	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Urinary Tract Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Urosepsis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Meniscus Injury	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Shoulder Fracture	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Tendon Rupture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Traumatic Arthrosis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Access Site Hematoma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Wrist Fracture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Cardiac Stress Test Abnormal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hyperkalemia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Knee Deformity	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Vertebral Foraminal Stenosis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Neoplasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage Iii	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Neoplasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Focal Dyscognitive Seizures	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Hemorrhagic Stroke	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Intracranial Pressure Increased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Migraine	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Primary Headache Associated With Sexual Activity	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Thalamic Infarction	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Transient Ischaemic Attack	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Pregnancy, puerperium and perinatal conditions Ruptured Ectopic Pregnancy	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Anxiety	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Depression	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Major Depression	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Suicidal Ideation	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Acute Kidney Injury	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Nephrolithiasis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Renal Mass	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Urinary Retention	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Heavy Menstrual Bleeding	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Ovarian Cyst	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Pelvic Organ Prolapse	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Rectocele	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Obstructive Sleep Apnea Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Cataract Operation	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Knee Operation	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Percutaneous Coronary Intervention	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertension	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertensive Crisis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertensive Emergency	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Varicose Vein	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Other adverse events

Measure	Renal Denervation n=182 participants at risk Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	Sham Procedure n=184 participants at risk Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Injury, poisoning and procedural complications Animal Bite	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Aphasia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Blood and lymphatic system disorders Anemia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Blood and lymphatic system disorders Mast Cell Activation Syndrome	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Angina Pectoris	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Aortic Valve Incompetence	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Atrial Fibrillation	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Atrial Flutter	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Atrioventricular Block	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Bradycardia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Bundle Branch Block Left	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Cardiac Arrest	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Cardiac Failure	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Coronary Artery Disease	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Extrasystoles	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Left Ventricular Hypertrophy	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Palpitations	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Sinus Arrest	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Sinus Bradycardia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Sinus Tachycardia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Supraventricular Tachycardia	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Stress	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Tachycardia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Cardiac disorders Ventricular Tachycardia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Ear and labyrinth disorders Ear Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Ear and labyrinth disorders Tinnitus	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Ear and labyrinth disorders Vertigo	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Endocrine disorders Goiter	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Endocrine disorders Hyperparathyroidism	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Endocrine disorders Hypothyroidism	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Conjunctival Hemorrhage	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Floppy Eyelid Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Iridocyclitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Ocular Hyperemia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Optic Nerve Disorder	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Vision Blurred	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Eye disorders Visual Impairment	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Abdominal Discomfort	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Abdominal Mass	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Abdominal Pain	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Angular Cheilitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Colitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Colitis Ulcerative	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Constipation	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Dental Caries	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Diarrhea	3.3% 6/182 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Diverticulum	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Dysphagia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Flatulence	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Gastritis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Hematochezia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Hemorrhoids	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Hiatus Hernia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Large Intestine Polyp	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Nausea	3.3% 6/182 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Oesophagitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Toothache	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Gastrointestinal disorders Vomiting	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Adverse Drug Reaction	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Asthenia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Axillary Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Chest Discomfort	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Chest Pain	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Drug Intolerance	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Fatigue	3.3% 6/182 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	4.9% 9/184 • Number of events 9 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Feeling Hot	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Gait Disturbance	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Impaired Healing	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Influenza Like Illness	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Malaise	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Medical Device Site Irritation	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Medical Device Site Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Medical Device Site Pruritus	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Medical Device Site Reaction	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Non-Cardiac Chest Pain	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	3.3% 6/184 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Oedema	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Oedema Peripheral	6.6% 12/182 • Number of events 12 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	8.2% 15/184 • Number of events 15 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Pain	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Peripheral Swelling	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Puncture Site Reaction	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Pyrexia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Swelling	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Swelling Face	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
General disorders Vessel Puncture Site Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Hepatobiliary disorders Cholelithiasis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Hepatobiliary disorders Hepatic Mass	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Immune system disorders Contrast Media Reaction	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Immune system disorders Drug Hypersensitivity	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Immune system disorders Hypersensitivity	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Immune system disorders Seasonal Allergy	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Abscess	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Acute Sinusitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Bacterial Vulvovaginitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Borrelia Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Bronchitis	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Cellulitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Conjunctivitis	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Covid-19	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Cystitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Diarrhea Infectious	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Ear Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Fungal Foot Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Fungal Skin Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Gastroenteritis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Gastrointestinal Viral Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations H1n1 Influenza	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Helicobacter Gastritis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Herpes Simplex	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Herpes Zoster	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Hordeolum	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Infection	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Influenza	4.4% 8/182 • Number of events 8 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	3.3% 6/184 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Labyrinthitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Localized Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Lower Respiratory Tract Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Lyme Disease	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Nasopharyngitis	6.0% 11/182 • Number of events 11 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	7.6% 14/184 • Number of events 14 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Oral Herpes	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Otitis Externa	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Paronychia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Pneumonia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Postoperative Wound Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Pyelonephritis Acute	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Respiratory Tract Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Rhinitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Sepsis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Sinusitis	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Skin Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Tonsillitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Tooth Abscess	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Trichomoniasis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Upper Respiratory Tract Infection	3.8% 7/182 • Number of events 7 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	3.3% 6/184 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Urinary Tract Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Vaginal Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Varicella	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Vestibular Neuronitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Viral Infection	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Viral Upper Respiratory Tract Infection	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Infections and infestations Vulvovaginal Mycotic Infection	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Arthropod Bite	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Burns Second Degree	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Chemical Burn Of Skin	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Concussion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Contusion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Corneal Abrasion	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Dislocation Of Vertebra	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Fall	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Foot Fracture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Head Injury	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Humerus Fracture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Incision Site Complication	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Incision Site Hematoma	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Incision Site Pain	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Injury	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Joint Injury	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Ligament Rupture	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Ligament Sprain	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Muscle Rupture	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Muscle Strain	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Post Procedural Hematoma	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Post Procedural Hemorrhage	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Procedural Hypotension	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Procedural Site Reaction	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Scratch	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Skin Laceration	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Spinal Column Injury	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Sternal Fracture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Tendon Injury	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Tendon Rupture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Thermal Burn	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Traumatic Arthrosis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Access Site Bruising	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Access Site Haematoma	8.8% 16/182 • Number of events 16 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	12.0% 22/184 • Number of events 22 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Access Site Hemorrhage	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Access Site Pain	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm Thrombosis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Injury, poisoning and procedural complications Wrist Fracture	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Cholesterol Increased	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Creatinine Increased	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Glucose Increased	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Magnesium Decreased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Potassium Decreased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Pressure Abnormal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Pressure Increased	2.7% 5/182 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Pressure Orthostatic Decreased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Pressure Systolic Increased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Blood Uric Acid Increased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations C-Reactive Protein Increased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Cardiac Murmur	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Cardiac Stress Test Abnormal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Glomerular Filtration Rate Decreased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Hemoglobin Abnormal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Hepatic Enzyme Increased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Lipids Increased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Occult Blood	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Oxygen Saturation Decreased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Renin Decreased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Respiratory Rate Decreased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Troponin Increased	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations Urine Analysis Abnormal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Investigations White Blood Cell Count Decreased	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Dehydration	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Diabetes Mellitus	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Gout	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hypercholesterolemia	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hyperkalemia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hyperlipidemia	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hypokalemia	2.7% 5/182 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Hypophagia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Insulin Resistance	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Iron Deficiency	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Obesity	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Ankylosing Spondylitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 12/182 • Number of events 12 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	7.1% 13/184 • Number of events 13 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Arthritis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Back Pain	6.6% 12/182 • Number of events 12 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	4.3% 8/184 • Number of events 8 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Groin Pain	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Joint Stiffness	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Joint Swelling	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.7% 5/184 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Knee Deformity	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Limb Discomfort	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Myalgia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Neck Pain	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Pain In Extremity	2.7% 5/182 • Number of events 5 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	4.3% 8/184 • Number of events 8 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Temporomandibular Joint Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Tendon Discomfort	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Musculoskeletal and connective tissue disorders Vertebral Foraminal Stenosis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Neoplasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinemia Benign Monoclonal	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage Iii	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Sleep Disorder	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neoplasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion Neoplasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid Tumor Benign	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Hamartoma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Cerebrovascular Accident	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Cranial Nerve Disorder	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Dizziness	8.2% 15/182 • Number of events 15 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	6.5% 12/184 • Number of events 12 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Dizziness Postural	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Drug Withdrawal Headache	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Electric Shock Sensation	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Encephalopathy	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Essential Tremor	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Focal Dyscognitive Seizures	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Headache	17.6% 32/182 • Number of events 32 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	16.8% 31/184 • Number of events 31 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Hemorrhagic Stroke	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Hypoesthesia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Lethargy	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Loss Of Consciousness	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Memory Impairment	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Migraine	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	4.3% 8/184 • Number of events 8 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Nerve Compression	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Orthostatic Intolerance	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Paresthesia	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Presyncope	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Primary Headache Associated With Sexual Activity	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Sciatica	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Somnolence	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Syncope	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Tension Headache	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Thalamic Infarction	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Transient Ischemic Attack	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Trigeminal Nerve Paresis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Nervous system disorders Trigeminal Neuralgia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Product Issues Device Physical Property Issue	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Alcohol Use Disorder	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Anxiety	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Depressed Mood	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Insomnia	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Intrusive Thoughts	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Post-Traumatic Stress Disorder	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Psychotic Disorder	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Restlessness	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Psychiatric disorders Vomiting Psychogenic	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Dysuria	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Hematuria	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Microalbuminuria	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Nephrolithiasis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Nocturia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Pollakiuria	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Renal Artery Occlusion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Renal Colic	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Renal Cyst	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Renal Mass	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Renal and urinary disorders Urinary Retention	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Breast Inflammation	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Breast Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Dyspareunia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Heavy Menstrual Bleeding	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Pelvic Organ Prolapse	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Reproductive system and breast disorders Prostatomegaly	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Asthma	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 4/182 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Dyspnea At Rest	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Dyspnea Exertional	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	3.3% 6/184 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Dyspnea Paroxysmal Nocturnal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Obstructive Sleep Apnea Syndrome	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Discomfort	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Blister	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Cold Sweat	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Dermal Cyst	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Dermatitis	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Eczema	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Pruritus	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Rash	1.6% 3/182 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Skin Discoloration	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Skin Fissures	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Skin Irritation	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Social circumstances Stress At Work	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Facet Joint Block	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Knee Operation	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Surgical and medical procedures Wisdom Teeth Removal	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Aortic Aneurysm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Arterial Spasm	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Circulatory Collapse	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Deep Vein Thrombosis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Embolism	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Flushing	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Giant Cell Arteritis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hot Flush	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.1% 2/184 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertension	5.5% 10/182 • Number of events 10 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	6.0% 11/184 • Number of events 11 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertensive Crisis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	1.6% 3/184 • Number of events 3 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertensive Emergency	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypertensive Urgency	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Hypotension	3.3% 6/182 • Number of events 6 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	2.2% 4/184 • Number of events 4 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Jugular Vein Distension	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Orthostatic Hypotension	1.1% 2/182 • Number of events 2 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Peripheral Coldness	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Peripheral Venous Disease	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Phlebitis	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.54% 1/184 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Systolic Hypertension	0.00% 0/182 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Vascular disorders Thrombophlebitis	0.55% 1/182 • Number of events 1 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.	0.00% 0/184 • All-Cause Mortality and Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 36 Months Post Procedure) while Other Adverse Events were monitored/assessed from subject enrollment (consent) through 12-month visits. The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Additional Information

Pamela McKenna, Sr. Principal Clinical Research Specialist

Medtronic

Phone: (773) 597-5241

Email: pamela.m.mckenna@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place