Trial Outcomes & Findings for STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR) (NCT NCT01927068)

NCT ID: NCT01927068

Last Updated: 2023-03-24

Results Overview

Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (TLR) through 12 months post-procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 499 participants
• Primary outcome timeframe: Through 12 months post-procedure.
• Results posted on: 2023-03-24

Participant Flow

Participant milestones

Measure	Global Cohort 1 The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.	ISR Cohort 2 The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Overall Study STARTED	370	129
Overall Study COMPLETED	262	121
Overall Study NOT COMPLETED	108	8

Reasons for withdrawal

Measure	Global Cohort 1 The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.	ISR Cohort 2 The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Overall Study Death	37	3
Overall Study Withdrawal by Subject	50	3
Overall Study Lost to Follow-up	10	2
Overall Study Physician Decision	9	0
Overall Study Missed last follow-up visit	2	0

Baseline Characteristics

The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.

Baseline characteristics by cohort

Measure	Global Cohort 1 n=370 Participants The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.	ISR Cohort 2 n=129 Participants Same patient population in Cohort 1, but cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.	Total n=499 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 9.3 • n=370 Participants	69 years STANDARD_DEVIATION 9.4 • n=129 Participants	NA years STANDARD_DEVIATION NA • n=499 Participants
Sex: Female, Male Female	99 Participants n=370 Participants	46 Participants n=129 Participants	145 Participants n=499 Participants
Sex: Female, Male Male	271 Participants n=370 Participants	83 Participants n=129 Participants	354 Participants n=499 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=370 Participants	1 Participants n=129 Participants	3 Participants n=499 Participants
Race/Ethnicity, Customized White	327 Participants n=370 Participants	128 Participants n=129 Participants	455 Participants n=499 Participants
Race/Ethnicity, Customized Asian	4 Participants n=370 Participants	0 Participants n=129 Participants	4 Participants n=499 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	2 Participants n=370 Participants	0 Participants n=129 Participants	2 Participants n=499 Participants
Race/Ethnicity, Customized Other	29 Participants n=370 Participants	0 Participants n=129 Participants	29 Participants n=499 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=370 Participants	0 Participants n=129 Participants	6 Participants n=499 Participants
Baseline Ankle-Brachial Index	0.70 ratio STANDARD_DEVIATION 0.20 • n=346 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.	0.66 ratio STANDARD_DEVIATION 0.18 • n=118 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.	NA ratio STANDARD_DEVIATION NA • n=464 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.
Baseline Rutherford-Becker Clinical Category RCC 1	1 Participants n=370 Participants	0 Participants n=129 Participants	1 Participants n=499 Participants
Baseline Rutherford-Becker Clinical Category RCC 2	124 Participants n=370 Participants	33 Participants n=129 Participants	157 Participants n=499 Participants
Baseline Rutherford-Becker Clinical Category RCC 3	213 Participants n=370 Participants	86 Participants n=129 Participants	299 Participants n=499 Participants
Baseline Rutherford-Becker Clinical Category RCC 4	23 Participants n=370 Participants	9 Participants n=129 Participants	32 Participants n=499 Participants
Baseline Rutherford-Becker Clinical Category RCC 5	9 Participants n=370 Participants	1 Participants n=129 Participants	10 Participants n=499 Participants
Peripheral Vascular Disease	295 Participants n=370 Participants	127 Participants n=129 Participants	422 Participants n=499 Participants
Hypertension	294 Participants n=370 Participants	102 Participants n=129 Participants	396 Participants n=499 Participants
Hyperlipidemia	276 Participants n=370 Participants	101 Participants n=129 Participants	377 Participants n=499 Participants
Coronary Heart Disease Myocardial Infarction	64 Participants n=370 Participants	21 Participants n=129 Participants	85 Participants n=499 Participants
Coronary Heart Disease Angina Pectoris	49 Participants n=370 Participants	10 Participants n=129 Participants	59 Participants n=499 Participants
Coronary Heart Disease Congestive Heart Failure	14 Participants n=370 Participants	11 Participants n=129 Participants	25 Participants n=499 Participants
Previous Percutaneous or Surgical Coronary Revascularization	123 Participants n=370 Participants	35 Participants n=129 Participants	158 Participants n=499 Participants
Renal Insufficency	26 Participants n=370 Participants	20 Participants n=129 Participants	46 Participants n=499 Participants
Liver Disease	12 Participants n=370 Participants	6 Participants n=129 Participants	18 Participants n=499 Participants
Cerebrovascular Disease	63 Participants n=370 Participants	25 Participants n=129 Participants	88 Participants n=499 Participants
Chronic Obstructive Pulmonary Disease (COPD)	49 Participants n=370 Participants	16 Participants n=129 Participants	65 Participants n=499 Participants
Deep Vein Trhombosis	8 Participants n=370 Participants	2 Participants n=129 Participants	10 Participants n=499 Participants
Diabetes Type I	5 Participants n=370 Participants	0 Participants n=129 Participants	5 Participants n=499 Participants
Diabetes Type II	119 Participants n=370 Participants	49 Participants n=129 Participants	168 Participants n=499 Participants
Smoker Never Smoked	66 Participants n=370 Participants	23 Participants n=129 Participants	89 Participants n=499 Participants
Smoker Previous or Current Smoker	304 Participants n=370 Participants	106 Participants n=129 Participants	410 Participants n=499 Participants

PRIMARY outcome

Timeframe: Through 12 months post-procedure.

Population: The Modified Intention-to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting. The primary analysis for both safety and efficacy will be based on the mITT population. In cohort 2, seven patients had bail-out stenting.

Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (TLR) through 12 months post-procedure.

Outcome measures

Measure	Global Cohort 1 n=370 Participants The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute	Global ISR Cohort 2 n=122 Participants The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	94.8 percentage of participants Interval 91.9 to 96.6	84.1 percentage of participants Interval 77.28 to 90.88

PRIMARY outcome

Timeframe: 12 months post-procedure.

Population: The Modified Intention-to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting. The primary analysis for both safety and efficacy will be based on the mITT population. In cohort 2, seven patients had bail-out stenting.

Primary patency at 12 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Outcome measures

Measure	Global Cohort 1 n=416 Lesions The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute	Global ISR Cohort 2 n=122 Lesions The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Percentage of Lesions Free From Restenosis	77.8 percentage of lesions Interval 73.2 to 81.9	58.8 percentage of lesions Interval 49.21 to 68.43

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: The Modified Intention to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting The primary analysis for safety and efficacy will be based on the mITT population In cohort 2, seven patients had bail-out stenting Data were only collected from Cohort 2 All data for prespecified Primary \& Secondary Outcome Measures should be reported.

The secondary efficacy outcome was freedom from target lesions revascularization (TLR) at 12 months post-procedure and compared to a performance goal.

Outcome measures

Measure	Global Cohort 1 n=122 Participants The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute	Global ISR Cohort 2 The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Secondary Efficacy Endpoint	83.5 percentage of participants Interval 75.4 to 89.7	—

Adverse Events

Global Cohort 1

Serious events: 291 serious events

Other events: 343 other events

Deaths: 37 deaths

Global ISR Cohort 2

Serious events: 65 serious events

Other events: 93 other events

Deaths: 3 deaths

Serious adverse events

Measure	Global Cohort 1 n=370 participants at risk The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute	Global ISR Cohort 2 n=122 participants at risk The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Surgical and medical procedures RADICAL PROSTATECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures SKIN NEOPLASM EXCISION	0.27% 1/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures SPINAL LAMINECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures TENDON OPERATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THROMBECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THROMBOLYSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THYROID OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders AORTIC ANEURYSM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders AORTIC STENOSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL HAEMORRHAGE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders Acute Myocardial Infarction	4.6% 17/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CATHETER SITE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders ANAEMIA	3.2% 12/370 • Number of events 12 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders AUTOIMMUNE HAEMOLYTIC ANAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders LYMPHADENOPATHY	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.9% 7/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ACUTE CORONARY SYNDROME	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ANGINA PECTORIS	3.2% 12/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ANGINA UNSTABLE	1.9% 7/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders AORTIC VALVE STENOSIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ARRHYTHMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ATRIAL FIBRILLATION	2.2% 8/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ATRIAL FLUTTER	1.1% 4/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC ARREST	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC DISORDER	0.27% 1/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE	2.7% 10/370 • Number of events 16 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE ACUTE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIOGENIC SHOCK	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders COR PULMONALE ACUTE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CORONARY ARTERY DISEASE	4.6% 17/370 • Number of events 20 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CORONARY ARTERY STENOSIS	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders DIASTOLIC DYSFUNCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders MYOCARDIAL INFARCTION	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders PALPITATIONS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders SICK SINUS SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders STRESS CARDIOMYOPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders TACHYARRHYTHMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders TACHYCARDIA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR FIBRILLATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR TACHYCARDIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIOMYOPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders DEAFNESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders MENIERE'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders VERTIGO	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders GOITRE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders HYPERPARATHYROIDISM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders CORNEAL DECOMPENSATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders ECTROPION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders ENTROPION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders EYE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders LAGOPHTHALMOS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders MACULAR FIBROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders EYELID PTOSIS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ABDOMINAL PAIN	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders BARRETT'S OESOPHAGUS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders COLITIS ULCERATIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DENTAL CARIES	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIARRHOEA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DUODENAL ULCER	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DYSPHAGIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DYSPEPSIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRIC ULCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTROINTESTINAL POLYP HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders HAEMATEMESIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEAL PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEUS PARALYTIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INGUINAL HERNIA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INGUINAL HERNIA STRANGULATED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL POLYP	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders LARGE INTESTINE POLYP	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders MELAENA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders MESENTERIC ARTERY STENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders OESOPHAGEAL RUPTURE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PANCREATITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PERIODONTAL INFLAMMATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PERITONEAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders UMBILICAL HERNIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders ADVERSE DRUG REACTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CALCINOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders CHEST PAIN	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEATH	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEVICE BATTERY ISSUE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEVICE MALFUNCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DEVICE OCCLUSION	3.5% 13/370 • Number of events 14 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	5.7% 7/122 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders HERNIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders IMPAIRED HEALING	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders IMPAIRED SELF-CARE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders INJECTION SITE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders MALAISE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PAIN	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders POLYP	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PUNCTURE SITE HAEMORRHAGE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PYREXIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders STENT-GRAFT ENDOLEAK	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders STENT MALFUNCTION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders SUDDEN DEATH	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders BILIARY COLIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLANGITIS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLECYSTITIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLELITHIASIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders HEPATIC LESION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders HEPATIC STEATOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Immune system disorders CONTRAST MEDIA ALLERGY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ABDOMINAL ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ABSCESS LIMB	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ANAL ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations APPENDICITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ARTHRITIS BACTERIAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BACTERAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BACTERIAL INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BLISTER INFECTED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BRONCHITIS	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BRONCHOPNEUMONIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CANDIDA INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CELLULITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CORONA VIRUS INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CYSTITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations DEVICE RELATED INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations DEVICE RELATED SEPSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ENDOCARDITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ERYSIPELAS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GANGRENE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GASTROENTERITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GROIN INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ILEAL GANGRENE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTION	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFLUENZA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LIVER ABSCESS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LOCALISED INFECTION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LUNG INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations MEDIASTINAL ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations MYCOTIC ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ORCHITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations OSTEOMYELITIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PELVIC ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PERITONITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PNEUMONIA	5.1% 19/370 • Number of events 24 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PSOAS ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PULPITIS DENTAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PYELONEPHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations RESPIRATORY TRACT INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SEPSIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SEPTIC SHOCK	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SINUSITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SOFT TISSUE INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations URINARY TRACT INFECTION	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations UROSEPSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations VIRAL INFECTION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations WOUND INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ARTERIAL RESTENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CONTUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CRANIOCEREBRAL INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FALL	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FEMUR FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FOOT FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications HIP FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications INJURY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications KIDNEY CONTUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications LIMB INJURY	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications MENISCUS INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PATELLA FRACTURE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PERIPHERAL ARTERIAL REOCCLUSION	3.0% 11/370 • Number of events 17 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PERIPHERAL ARTERY RESTENOSIS	10.5% 39/370 • Number of events 54 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	4.9% 6/122 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL FISTULA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PUBIS FRACTURE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications REOCCLUSION	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications RIB FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SEROMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPINAL FRACTURE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TENDON INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TOOTH INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TRACHEAL INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND EVISCERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WRIST FRACTURE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ANGIOGRAM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ANGIOGRAM PERIPHERAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BLOOD URINE PRESENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BORDETELLA TEST POSITIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations HAEMOGLOBIN DECREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations INVESTIGATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations LYMPH NODES SCAN ABNORMAL	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders CACHEXIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders DEHYDRATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders DIABETES MELLITUS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders FLUID OVERLOAD	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.27% 1/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERKALAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERNATRAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPOKALAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders OBESITY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ARTHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders BACK PAIN	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders BURSITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders COMPARTMENT SYNDROME	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders GROIN PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders NECK PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	2.4% 9/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PLANTAR FASCIAL FIBROMATOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANOGENITAL WARTS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER NEOPLASM	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EAR NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED RECURRENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOCYTIC LEUKAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MAXILLOFACIAL SINUS NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OROPHARYNGEAL SQUAMOUS CELL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER RECURRENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATIC ADENOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR OF AMPULLA OF VATER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URETHRAL CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CAROTID ARTERY STENOSIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CARPAL TUNNEL SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBRAL ARTERY OCCLUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBRAL ISCHAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DEMENTIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DIZZINESS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders FACIAL SPASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders LACUNAR INFARCTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders MOTOR NEURONE DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders NORMAL PRESSURE HYDROCEPHALUS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PARAESTHESIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PARKINSON'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PRESYNCOPE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders RADICULOPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders SYNCOPE	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.9% 7/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders VIITH NERVE PARALYSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders AGGRESSION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders CONFUSIONAL STATE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders DELIRIUM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders DEPRESSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders MENTAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders BLADDER PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders HAEMATURIA	0.81% 3/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders HAEMORRHAGE URINARY TRACT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders MICTURITION DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders NEPHROLITHIASIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders NOCTURIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL ARTERY STENOSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL FAILURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL FAILURE ACUTE	3.2% 12/370 • Number of events 12 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL FAILURE CHRONIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL IMPAIRMENT	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL DILATATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL MEATUS STENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL STENOSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URINARY RETENTION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders PROSTATIC HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders PROSTATITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders VAGINAL PROLAPSE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders BRONCHIAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	2.7% 10/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders COUGH	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX SPONTANEOUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	1.6% 6/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMATITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMATOMYOSITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DIABETIC FOOT	1.1% 4/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders PETECHIAE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders PSORIASIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders SKIN ULCER	1.6% 6/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ANGIOPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ALCOHOL DETOXIFICATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures CARDIAC OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures DEBRIDEMENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures DUPUYTREN'S CONTRACTURE OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures EYE OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures GASTROSTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures HIP ARTHROPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures HIP SURGERY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ILEOSTOMY CLOSURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures INTESTINAL RESECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures KNEE OPERATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures LEG AMPUTATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures LIVER ABLATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures MEDICAL DEVICE CHANGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures NASAL CYST REMOVAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures OESOPHAGECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL ARTERY ANGIOPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL ARTERY BYPASS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL REVASCULARISATION	1.1% 4/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL SPASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL STENOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIOSCLEROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIOVENOUS FISTULA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders EXTREMITY NECROSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FEMORAL ARTERY DISSECTION	8.6% 32/370 • Number of events 32 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FEMORAL ARTERY OCCLUSION	7.3% 27/370 • Number of events 33 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FLUSHING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMATOMA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMODYNAMIC INSTABILITY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPERTENSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPERTENSIVE CRISIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPOTENSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPOVOLAEMIC SHOCK	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ILIAC ARTERY OCCLUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders INTERMITTENT CLAUDICATION	9.2% 34/370 • Number of events 44 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	4.9% 6/122 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders MACROANGIOPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ORTHOSTATIC HYPOTENSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	4.3% 16/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY DISSECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY STENOSIS	24.6% 91/370 • Number of events 132 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	13.1% 16/122 • Number of events 23 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL EMBOLISM	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ISCHAEMIA	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL VASCULAR DISORDER	1.1% 4/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders TEMPORAL ARTERITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VARICOSE VEIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VASCULAR CALCIFICATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VASOSPASM	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VESSEL PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,

Other adverse events

Measure	Global Cohort 1 n=370 participants at risk The purpose of this single arm cohort is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute	Global ISR Cohort 2 n=122 participants at risk The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1. All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX). Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Renal and urinary disorders RENAL FAILURE ACUTE	4.1% 15/370 • Number of events 16 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL FAILURE CHRONIC	1.9% 7/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL HYPERTENSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL IMPAIRMENT	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GANGRENE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GASTROENTERITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders MENTAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders POST-TRAUMATIC STRESS DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders NOCTURIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders PRERENAL FAILURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL ARTERY STENOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders BLADDER PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders CALCULUS BLADDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders CALCULUS URINARY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders RENAL FAILURE	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders HAEMATURIA	2.2% 8/370 • Number of events 11 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CATHETER SITE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders ANAEMIA	4.6% 17/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders AUTOIMMUNE HAEMOLYTIC ANAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders HAEMORRHAGIC DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders IMMUNE THROMBOCYTOPENIC PURPURA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders LYMPHADENOPATHY	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Blood and lymphatic system disorders THROMBOCYTOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.6% 6/370 • Number of events 12 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ACUTE CORONARY SYNDROME	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	4.9% 18/370 • Number of events 19 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ANGINA PECTORIS	4.3% 16/370 • Number of events 19 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ANGINA UNSTABLE	1.9% 7/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders AORTIC VALVE STENOSIS	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ARRHYTHMIA	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ATRIAL FIBRILLATION	6.5% 24/370 • Number of events 27 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders ATRIAL FLUTTER	1.4% 5/370 • Number of events 17 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders BRADYARRHYTHMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders BRADYCARDIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC ARREST	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE	3.0% 11/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC FAILURE ACUTE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIAC SEPTAL HYPERTROPHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIOGENIC SHOCK	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CARDIOMYOPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders COR PULMONALE ACUTE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CORONARY ARTERY DISEASE	4.6% 17/370 • Number of events 21 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders CORONARY ARTERY STENOSIS	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders DIASTOLIC DYSFUNCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders MITRAL VALVE INCOMPETENCE	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders MYOCARDIAL INFARCTION	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders PALPITATIONS	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders PERICARDIAL EFFUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders PRINZMETAL ANGINA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders SICK SINUS SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders STRESS CARDIOMYOPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders TACHYARRHYTHMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders TACHYCARDIA	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR FIBRILLATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Cardiac disorders VENTRICULAR TACHYCARDIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Congenital, familial and genetic disorders HAMARTOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Congenital, familial and genetic disorders HYDROCELE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders DEAFNESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders MENIERE'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Ear and labyrinth disorders VERTIGO	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders GOITRE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders HYPERPARATHYROIDISM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders HYPERTHYROIDISM	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders HYPOTHYROIDISM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Endocrine disorders THYROID CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders AMAUROSIS FUGAX	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders CATARACT	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders CORNEAL DECOMPENSATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders DIABETIC RETINOPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders HAEMORRHAGE URINARY TRACT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders ECTROPION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders ENTROPION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders EYE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders EYELID PTOSIS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders LAGOPHTHALMOS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders MACULAR FIBROSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders RETINAL VEIN OCCLUSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Eye disorders RETINOPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ABDOMINAL PAIN	1.6% 6/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders BARRETT'S OESOPHAGUS	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders COLITIS ULCERATIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders CONSTIPATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DENTAL CARIES	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIAPHRAGMATIC HERNIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIARRHOEA	1.6% 6/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIVERTICULITIS INTESTINAL HAEMORRHAGIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIVERTICULUM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DUODENAL ULCER	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DYSPEPSIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders DYSPHAGIA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRIC POLYPS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRIC ULCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTRITIS	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTROINTESTINAL POLYP HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders GINGIVAL BLEEDING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders HAEMATEMESIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders HAEMORRHOIDS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders HAEMORRHOIDS THROMBOSED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEAL PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders ILEUS PARALYTIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INGUINAL HERNIA	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INGUINAL HERNIA STRANGULATED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders INTESTINAL POLYP	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders LARGE INTESTINE POLYP	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders MELAENA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders MESENTERIC ARTERY STENOSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders NAUSEA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders OESOPHAGEAL RUPTURE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders OESOPHAGITIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PANCREATIC CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PANCREATIC MASS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PANCREATITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PERIODONTAL INFLAMMATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders PERITONEAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders TOOTHACHE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Gastrointestinal disorders UMBILICAL HERNIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders ADVERSE DRUG REACTION	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders ASTHENIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CALCINOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE BRUISE	1.1% 4/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE DISCHARGE	1.9% 7/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE HAEMATOMA	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE HAEMORRHAGE	1.9% 7/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CATHETER SITE RELATED REACTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CHEST DISCOMFORT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CHEST PAIN	3.5% 13/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	2.5% 3/122 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEATH	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEVICE BATTERY ISSUE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEVICE MALFUNCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DEVICE OCCLUSION	4.1% 15/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	7.4% 9/122 • Number of events 11 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DISCOMFORT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders DRUG INTOLERANCE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders EFFUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders EXERCISE TOLERANCE DECREASED	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders FATIGUE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders HERNIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders IMPAIRED HEALING	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders IMPAIRED SELF-CARE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders INJECTION SITE HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders LOCAL SWELLING	2.4% 9/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders MALAISE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders OBSTRUCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders OEDEMA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders OEDEMA PERIPHERAL	2.4% 9/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PAIN	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders POLYP	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PUNCTURE SITE DISCHARGE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PUNCTURE SITE HAEMORRHAGE	1.1% 4/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PUNCTURE SITE PAIN	1.1% 4/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders PYREXIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders STENT-GRAFT ENDOLEAK	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders STENT MALFUNCTION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders SUDDEN DEATH	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders SWELLING	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders THROMBOSIS IN DEVICE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders VESSEL PUNCTURE SITE DISCHARGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders BILIARY COLIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLANGITIS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLECYSTITIS	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders CHOLELITHIASIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders HEPATIC ARTERY STENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders HEPATIC LESION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Hepatobiliary disorders HEPATIC STEATOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Immune system disorders CONTRAST MEDIA ALLERGY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Immune system disorders HYPERSENSITIVITY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ABDOMINAL ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ABSCESS LIMB	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ANAL ABSCESS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations APPENDICITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ARTHRITIS BACTERIAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BACTERAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BACTERIAL INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BACTERIURIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BLISTER INFECTED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BRONCHITIS	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations BRONCHOPNEUMONIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CANDIDA INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CELLULITIS	0.81% 3/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CORONA VIRUS INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations CYSTITIS	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations DEVICE RELATED INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations DEVICE RELATED SEPSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations DIVERTICULITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations EAR INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ENDOCARDITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ENTEROCOCCAL INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ERYSIPELAS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations FURUNCLE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GASTROENTERITIS NOROVIRUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations GROIN INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations HELICOBACTER INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations HERPES ZOSTER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ILEAL GANGRENE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTED BITES	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTED DERMAL CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTED LYMPHOCELE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTION	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations INFLUENZA	1.9% 7/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LIVER ABSCESS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LOCALISED INFECTION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations LUNG INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations MEDIASTINAL ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations MYCOTIC ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations NAIL BED INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations NASOPHARYNGITIS	1.9% 7/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations ORCHITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations OSTEOMYELITIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations OTITIS MEDIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PELVIC ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PERITONITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PHARYNGITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PNEUMONIA	5.7% 21/370 • Number of events 27 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PSOAS ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PULPITIS DENTAL	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations PYELONEPHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations RESPIRATORY TRACT INFECTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SEPSIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SEPTIC SHOCK	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders KIDNEY ENLARGEMENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SIALOADENITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SINUSITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SKIN INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SOFT TISSUE INFECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations SUBCUTANEOUS ABSCESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.1% 4/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations URINARY TRACT INFECTION	3.2% 12/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations UROSEPSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations VIRAL INFECTION	1.1% 4/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Infections and infestations WOUND INFECTION	0.81% 3/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ARTERIAL RESTENOSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	5.7% 7/122 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications BREAST INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications BURNS THIRD DEGREE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CAROTID ARTERY RESTENOSIS	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CONCUSSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CONTUSION	2.4% 9/370 • Number of events 11 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FALL	2.7% 10/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FEMUR FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications FOOT FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications HAND FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications HIP FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications INFLAMMATION OF WOUND	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications INJURY	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications JOINT DISLOCATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications JOINT INJURY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications KIDNEY CONTUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications LACERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications LIMB INJURY	1.9% 7/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications MENISCUS INJURY	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications NAIL INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PATELLA FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PERIPHERAL ARTERIAL REOCCLUSION	3.5% 13/370 • Number of events 24 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PERIPHERAL ARTERY RESTENOSIS	18.9% 70/370 • Number of events 103 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	8.2% 10/122 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL FISTULA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POST PROCEDURAL SWELLING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PROCEDURAL HEADACHE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PROCEDURAL HYPERTENSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications PUBIS FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications RADIUS FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications REOCCLUSION	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications RIB FRACTURE	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SCAPULA FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SEROMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SKIN WOUND	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPINAL FRACTURE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TENDON INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TENDON RUPTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TOOTH INJURY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications TRACHEAL INJURY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications URINARY RETENTION POSTOPERATIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	2.4% 9/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	4.9% 6/122 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND EVISCERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WOUND NECROSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Injury, poisoning and procedural complications WRIST FRACTURE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ANGIOGRAM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ANGIOGRAM PERIPHERAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ANKLE BRACHIAL INDEX DECREASED	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BLOOD CREATININE INCREASED	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BLOOD GLUCOSE ABNORMAL	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BLOOD URINE PRESENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BODY TEMPERATURE DECREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations BORDETELLA TEST POSITIVE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations C-REACTIVE PROTEIN INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations CARDIAC MURMUR	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations COMA SCALE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ELECTROCARDIOGRAM ST SEGMENT ELEVATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations ENDOSCOPY UPPER GASTROINTESTINAL TRACT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations GLYCOSYLATED HAEMOGLOBIN INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations HAEMOGLOBIN DECREASED	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations INVESTIGATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations LYMPH NODES SCAN ABNORMAL	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Investigations RED BLOOD CELL COUNT DECREASED	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders CACHEXIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders DEHYDRATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders DIABETES MELLITUS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders FLUID OVERLOAD	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders GOUT	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERCALCAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.81% 3/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERKALAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERNATRAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders MICTURITION DISORDER	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPERURICAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPOKALAEMIA	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders HYPONATRAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders IRON DEFICIENCY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders MALNUTRITION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders OBESITY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.1% 15/370 • Number of events 16 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ARTHRITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders BACK PAIN	5.7% 21/370 • Number of events 22 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	6.6% 8/122 • Number of events 10 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders BURSITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders COMPARTMENT SYNDROME	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders EXOSTOSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders FLANK PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders GOUTY ARTHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders GROIN PAIN	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders LIMB DISCOMFORT	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCLE ATROPHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	3.8% 14/370 • Number of events 14 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	1.9% 7/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders MYOSCLEROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders NECK PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	4.9% 18/370 • Number of events 21 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders OSTEOPENIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	11.6% 43/370 • Number of events 49 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	5.7% 7/122 • Number of events 11 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PLANTAR FASCIAL FIBROMATOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders PLANTAR FASCIITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders SCOLIOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders SENSATION OF HEAVINESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Musculoskeletal and connective tissue disorders TENDONITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADRENAL ADENOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANOGENITAL WARTS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.81% 3/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER NEOPLASM	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders NEPHROLITHIASIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EAR NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF SKIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF LIVER	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KERATOACANTHOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA OF BREAST	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED RECURRENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders NEPHROPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOCYTIC LEUKAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MAXILLOFACIAL SINUS NEOPLASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OROPHARYNGEAL SQUAMOUS CELL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC NEOPLASM	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER RECURRENT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATIC ADENOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR OF AMPULLA OF VATER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URETHRAL CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders BALANCE DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders BURNING SENSATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CAROTID ARTERY OCCLUSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CAROTID ARTERY STENOSIS	2.4% 9/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	2.5% 3/122 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CARPAL TUNNEL SYNDROME	0.81% 3/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBRAL ARTERY OCCLUSION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBRAL HAEMATOMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBRAL ISCHAEMIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders COGNITIVE DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DEMENTIA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DIZZINESS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	2.5% 3/122 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders DYSAESTHESIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders EPILEPSY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders FACIAL SPASM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders HEADACHE	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders HEMIPLEGIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders HYPOTONIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders LACUNAR INFARCTION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders LOSS OF CONSCIOUSNESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders MOTOR NEURONE DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders NEURALGIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders NEURITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders NEUROPATHY PERIPHERAL	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders NORMAL PRESSURE HYDROCEPHALUS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PARAESTHESIA	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PARKINSON'S DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PERONEAL NERVE PALSY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PHANTOM PAIN	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders POLYNEUROPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders PRESYNCOPE	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders RADICULITIS LUMBOSACRAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders RADICULOPATHY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders RESTLESS LEGS SYNDROME	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders SCIATICA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders SENSORY LOSS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders SYNCOPE	3.0% 11/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	2.4% 9/370 • Number of events 10 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders TREMOR	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders VASCULAR DEMENTIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Nervous system disorders VIITH NERVE PARALYSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders AGGRESSION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders ANXIETY	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders BREATHING-RELATED SLEEP DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders CONFUSIONAL STATE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders DELIRIUM	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders DEPRESSION	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Psychiatric disorders EMOTIONAL DISTRESS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL DILATATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL MEATUS STENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URETHRAL STENOSIS	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URINARY INCONTINENCE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Renal and urinary disorders URINARY RETENTION	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders ATROPHIC VULVOVAGINITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders PROSTATIC HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders PROSTATISM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders PROSTATITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Reproductive system and breast disorders VAGINAL PROLAPSE	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders ASTHMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders BRONCHIAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	3.5% 13/370 • Number of events 17 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders COUGH	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders DYSPNOEA	4.1% 15/370 • Number of events 16 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.2% 8/370 • Number of events 10 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders HYPERVENTILATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders HYPOVENTILATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX SPONTANEOUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	1.9% 7/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders PULMONARY VASCULAR DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Respiratory, thoracic and mediastinal disorders VOCAL CORD LEUKOPLAKIA	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders COLD SWEAT	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMAL CYST	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMATITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DERMATOMYOSITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders DIABETIC FOOT	1.1% 4/370 • Number of events 9 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders ECCHYMOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders ECZEMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders ERYTHEMA	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders HYPERSENSITIVITY VASCULITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders INTERTRIGO	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders PETECHIAE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders PRURITUS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders PSORIASIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders RASH	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders SKIN HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders SKIN LESION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders SKIN ULCER	1.9% 7/370 • Number of events 18 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders STASIS DERMATITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders SWELLING FACE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Skin and subcutaneous tissue disorders URTICARIA	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ALCOHOL DETOXIFICATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ANGIOPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures CARDIAC OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures DEBRIDEMENT	0.27% 1/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures DUPUYTREN'S CONTRACTURE OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures EYE OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures GASTROSTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures HIP ARTHROPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures HIP SURGERY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures ILEOSTOMY CLOSURE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures INTESTINAL RESECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures KNEE OPERATION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures LEG AMPUTATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures LIVER ABLATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures MEDICAL DEVICE CHANGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures NASAL CYST REMOVAL	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures NERVE BLOCK	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures OESOPHAGECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL ARTERY ANGIOPLASTY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL ARTERY BYPASS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures PERIPHERAL REVASCULARISATION	1.4% 5/370 • Number of events 7 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures POLYPECTOMY	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures RADICAL PROSTATECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures SKIN NEOPLASM EXCISION	0.27% 1/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures SPINAL LAMINECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures TENDON OPERATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THROMBECTOMY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THROMBOLYSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Surgical and medical procedures THYROID OPERATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders AORTIC ANEURYSM	1.4% 5/370 • Number of events 5 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders AORTIC DILATATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders AORTIC STENOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL DISORDER	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL HAEMORRHAGE	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL SPASM	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIAL STENOSIS	1.4% 5/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	4.1% 5/122 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIOSCLEROSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERIOVENOUS FISTULA	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ARTERY DISSECTION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders DEEP VEIN THROMBOSIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ENDOTHELIAL DYSFUNCTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders EXTREMITY NECROSIS	0.54% 2/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FEMORAL ARTERY ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FEMORAL ARTERY DISSECTION	9.5% 35/370 • Number of events 36 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FEMORAL ARTERY OCCLUSION	10.8% 40/370 • Number of events 50 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	4.1% 5/122 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FIBROMUSCULAR DYSPLASIA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders FLUSHING	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMATOMA	3.5% 13/370 • Number of events 14 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	3.3% 4/122 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMODYNAMIC INSTABILITY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HOT FLUSH	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPERTENSION	3.2% 12/370 • Number of events 13 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPERTENSIVE CRISIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPOTENSION	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders HYPOVOLAEMIC SHOCK	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ILIAC ARTERY OCCLUSION	0.27% 1/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders INTERMITTENT CLAUDICATION	24.3% 90/370 • Number of events 127 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	11.5% 14/122 • Number of events 16 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders JUGULAR VEIN THROMBOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders LYMPHOEDEMA	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders MACROANGIOPATHY	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders ORTHOSTATIC HYPOTENSION	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PENETRATING ATHEROSCLEROTIC ULCER	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	8.4% 31/370 • Number of events 39 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	1.6% 2/122 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY DISSECTION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY STENOSIS	38.1% 141/370 • Number of events 260 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	20.5% 25/122 • Number of events 45 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL EMBOLISM	1.6% 6/370 • Number of events 6 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL ISCHAEMIA	2.2% 8/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders PERIPHERAL VASCULAR DISORDER	1.6% 6/370 • Number of events 8 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders POOR PERIPHERAL CIRCULATION	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders RAYNAUD'S PHENOMENON	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders SUBCLAVIAN ARTERY STENOSIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders TEMPORAL ARTERITIS	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders THROMBOPHLEBITIS	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders THROMBOSIS	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VARICOSE VEIN	0.81% 3/370 • Number of events 3 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VASCULAR CALCIFICATION	0.81% 3/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VASCULAR RUPTURE	0.00% 0/370 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VASOSPASM	1.1% 4/370 • Number of events 4 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VENOUS HAEMORRHAGE	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VENOUS INSUFFICIENCY	0.54% 2/370 • Number of events 2 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.00% 0/122 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,
Vascular disorders VESSEL PERFORATION	0.27% 1/370 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,	0.82% 1/122 • Number of events 1 • For cohort 1, the adverse event data reflects 60 months of follow-up post-procedure. For cohort 2, the adverse event data is through 12-months follow-up post-procedure,

Additional Information

Associate Director, Clinical Operations

Spectranetics LLC, now part of Philips Image Guided Therapy

Phone: 612-297-6655

Email: nicolas.aguirre@philips.com

Results disclosure agreements

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