Trial Outcomes & Findings for Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (NCT NCT02000115)
NCT ID: NCT02000115
Last Updated: 2025-07-20
Results Overview
A composite of all-cause mortality or disabling stroke at one year.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1242 participants
Primary outcome timeframe
One-year from randomization
Results posted on
2025-07-20
Participant Flow
750 subjects were randomized (1:1) to the Portico valve (n=381) and CAV (n=369) groups. 100 analysis subjects were enrolled in the FlexNav Delivery System study. 53 subjects are currently enrolled in the IDE Valve-in-Valve registry ( enrollment ongoing)
Only the Randomized IDE cohort (N=750) and FlexNav Delivery System Study (N=100 analysis) that completed subject enrollment and reached their pre-defined primary endpoint(s) are included in the Results Section. The IDE Valve-in-Valve registry is still enrolling subjects. A total of 53 out of a required 100 subjects have been enrolled to date.
Participant milestones
| Measure |
Randomized IDE Cohort, Portico Valve
Portico transcatheter aortic valve and Portico delivery System.
|
Randomized IDE Cohort, CAV
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
FlexNav Delivery System Study
Portico transcatheter aortic valve and FlexNav delivery system
|
Nested Valve-in-Valve Registry
Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
381
|
369
|
100
|
53
|
|
Overall Study
COMPLETED
|
302
|
301
|
99
|
0
|
|
Overall Study
NOT COMPLETED
|
79
|
68
|
1
|
53
|
Reasons for withdrawal
| Measure |
Randomized IDE Cohort, Portico Valve
Portico transcatheter aortic valve and Portico delivery System.
|
Randomized IDE Cohort, CAV
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
FlexNav Delivery System Study
Portico transcatheter aortic valve and FlexNav delivery system
|
Nested Valve-in-Valve Registry
Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve
|
|---|---|---|---|---|
|
Overall Study
Death
|
56
|
45
|
0
|
0
|
|
Overall Study
Missed Visit
|
6
|
8
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
11
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawn on day of randomization
|
0
|
1
|
0
|
0
|
|
Overall Study
Still on Study
|
0
|
0
|
0
|
53
|
Baseline Characteristics
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Baseline characteristics by cohort
| Measure |
Randomized IDE Cohort, Portico Valve
n=381 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=369 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
FlexNav Delivery System Study
n=100 Participants
Portico transcatheter aortic valve and FlexNav delivery system
|
Total
n=850 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
83.0 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
83.7 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
85.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
83.5 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
452 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
398 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
354 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
785 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
351 participants
n=5 Participants
|
340 participants
n=7 Participants
|
75 participants
n=5 Participants
|
796 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
25 participants
n=5 Participants
|
88 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One-year from randomizationPopulation: Intention-to-treat analysis population.
A composite of all-cause mortality or disabling stroke at one year.
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=381 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=369 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Primary Effectiveness Endpoint (Randomized IDE Cohort)
|
14.8 percentage of participants
Standard Error 1.8
|
13.4 percentage of participants
Standard Error 1.8
|
PRIMARY outcome
Timeframe: 30 days from randomizationPopulation: Intention-to-treat analysis population
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days.
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=381 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=369 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Primary Safety Endpoint (Randomized IDE Cohort)
|
13.8 percentage of participants
Standard Deviation 1.8
|
9.6 percentage of participants
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 30 days from index procedurePopulation: All enrolled analysis subjects
Valve Academic Research Consortium (VARC) 2- defined major vascular complications
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=100 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)
|
6.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: One yearPopulation: All randomized subjects with available data at one-year
Severe aortic regurgitation (AR) at one year
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=269 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=269 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)
|
0.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: One yearPopulation: All randomized subjects with available data at one-year
Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Scale 0 to 100; with higher scores indicating better symptoms and physical functioning
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=274 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=283 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)
|
75.4 units on a scale
Standard Deviation 22.2
|
75.9 units on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: One yearPopulation: All randomized subjects with available data at one-year
Moderate or severe aortic regurgitation at one year
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=269 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=269 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)
|
7.1 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: One yearPopulation: All randomized subjects with available data at one-year
Six-minute walk distance at one year
Outcome measures
| Measure |
Randomized IDE Cohort, Portico Valve
n=227 Participants
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=225 Participants
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
|---|---|---|
|
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)
|
235.0 meters
Standard Deviation 125.0
|
231.5 meters
Standard Deviation 118.5
|
SECONDARY outcome
Timeframe: 30 days from index procedureNon-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days from index procedure. Anticipated completion date (2022)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year from index procedureA composite of all-cause mortality or disabling stroke at one year Anticipated completion data (2023)
Outcome measures
Outcome data not reported
Adverse Events
Randomized IDE Cohort, Portico Valve
Serious events: 273 serious events
Other events: 298 other events
Deaths: 56 deaths
Randomized IDE Cohort, CAV
Serious events: 231 serious events
Other events: 269 other events
Deaths: 45 deaths
FlexNav Delivery System Study
Serious events: 44 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized IDE Cohort, Portico Valve
n=381 participants at risk
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=369 participants at risk
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
FlexNav Delivery System Study
n=100 participants at risk
Portico transcatheter aortic valve and FlexNav delivery system
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
2.9%
11/381 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Aorta- Aortic Calcification
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Aortic- Aortic Dissection
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Arrhythmias
|
10.0%
38/381 • Number of events 43 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
9.2%
34/369 • Number of events 42 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.0%
4/100 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Arterial Hypertension
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.9%
7/369 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
EKG Abnormalities
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Echo finding
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Endocarditis- Infective/Bacterial Endocarditis
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Endocarditis- Prosthetic Valvular Endocarditis (PVE)
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Asystole
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Cardiac Arrest
|
2.9%
11/381 • Number of events 12 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Cardiac Perforation
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Cardiomyopathy
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Coronary Artery Disease
|
0.52%
2/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Coronary Artery Occlusion
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Hypertensive Crisis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Hypervolemia
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Myocardial Ischemia
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Pericardial Effusion
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.1%
4/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Pericardial Tamponade
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Pericarditis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General-Pulmonary Hypertension
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Cardiovascular Symptoms
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Heart Block
|
25.7%
98/381 • Number of events 102 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
10.0%
37/369 • Number of events 39 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
12.0%
12/100 • Number of events 12 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Heart Failure
|
14.7%
56/381 • Number of events 79 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
10.6%
39/369 • Number of events 52 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
3/100 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Hypotension
|
2.4%
9/381 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
7.0%
7/100 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Myocardial Infarction
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Shock
|
1.6%
6/381 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Aortic Valve Stenosis
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Mitral Valve Regurgitation/Mitral Insufficiency
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Mitral Valve Stenosis
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Perivalvular Leak
|
3.4%
13/381 • Number of events 13 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Tricuspid Valve
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Skin and subcutaneous tissue disorders
General-Dematological
|
1.0%
4/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Nose and Paranasal Sinuses
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Throat- Cough
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
Disorders of Carbohydrate Metabolism
|
3.7%
14/381 • Number of events 16 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
11/369 • Number of events 13 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
General- Fluid, Electrolyte, Endocine and Metabolic Disorders
|
3.7%
14/381 • Number of events 15 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.4%
9/369 • Number of events 10 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Diverticulitis
|
0.79%
3/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Esophageal Laceration and Rupture
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
General-Gastrointestinal Disorders
|
8.1%
31/381 • Number of events 36 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
6.8%
25/369 • Number of events 26 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
3/100 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
General-Gastrointestinal Symptoms
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Hepatic and Biliary Disorders
|
0.79%
3/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
General-Genitourinary Disorders
|
5.5%
21/381 • Number of events 22 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.6%
17/369 • Number of events 19 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
General-Genitourinary Symptoms
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Prostate Disease
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Renal Failure
|
2.9%
11/381 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.4%
9/369 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.4%
9/381 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.8%
14/369 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
3/100 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Blood and lymphatic system disorders
Anemias
|
9.4%
36/381 • Number of events 37 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
8.7%
32/369 • Number of events 35 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.0%
4/100 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Blood and lymphatic system disorders
General-Hematology and Oncology
|
11.3%
43/381 • Number of events 48 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.7%
21/369 • Number of events 29 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
13.0%
13/100 • Number of events 18 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Infections and infestations
Fungal Infection
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Infections and infestations
General- Infections
|
3.7%
14/381 • Number of events 16 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.8%
14/369 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Allergy
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Miscellaneous- Device Malposition or Malfunction
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Miscellaneous- Device Migration
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Miscellaneous-Thrombus on Device
|
1.3%
5/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Miscellaneous- General
|
15.7%
60/381 • Number of events 68 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
16.3%
60/369 • Number of events 70 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.0%
4/100 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.9%
11/381 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
11/369 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
General-Musculoskeletal and Connective Tissue Disorders
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
General- Musculoskeletal Symptoms
|
2.1%
8/381 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
General-Neurological
|
8.7%
33/381 • Number of events 34 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.9%
18/369 • Number of events 25 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.0%
5/100 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
General- Neurological Symptoms
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Hemorrhage
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Neurological Hematoma
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Stroke
|
2.9%
11/381 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.9%
18/369 • Number of events 20 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airway Disorders
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
General- Pulmonary/Respiratory Disorders
|
9.4%
36/381 • Number of events 48 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
7.0%
26/369 • Number of events 28 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
3/100 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic Pneumonias
|
0.52%
2/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorders
|
3.1%
12/381 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.4%
9/369 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
3/100 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.8%
26/381 • Number of events 29 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.3%
16/369 • Number of events 16 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Bleeding
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Hematoma
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Pseudoaneurysm
|
2.1%
8/381 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.1%
4/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vascular Rupture
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vessel Dissection
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vessel Perforation
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vessel Stenosis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Hypovolemia
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
Other adverse events
| Measure |
Randomized IDE Cohort, Portico Valve
n=381 participants at risk
Portico transcatheter aortic valve and Portico delivery system
|
Randomized IDE Cohort, CAV
n=369 participants at risk
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
|
FlexNav Delivery System Study
n=100 participants at risk
Portico transcatheter aortic valve and FlexNav delivery system
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
2.9%
11/381 • Number of events 12 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.4%
9/369 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Aortic-Aortic Dissection
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Arrhythmias
|
14.2%
54/381 • Number of events 60 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
12.2%
45/369 • Number of events 50 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
11.0%
11/100 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Arterial Hypertension
|
5.0%
19/381 • Number of events 19 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.7%
10/369 • Number of events 10 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
EKG Abnormalities
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.1%
4/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Echo Finding
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General
|
6.0%
23/381 • Number of events 23 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.1%
19/369 • Number of events 20 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
8.0%
8/100 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
General- Cardiovascular Symptoms
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Heart Block
|
26.8%
102/381 • Number of events 114 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
22.5%
83/369 • Number of events 91 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
19.0%
19/100 • Number of events 20 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Heart Failure
|
5.8%
22/381 • Number of events 23 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
6.0%
22/369 • Number of events 22 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Hypotension
|
3.9%
15/381 • Number of events 15 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
11/369 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Myocardial Infarction
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve-Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
|
4.2%
16/381 • Number of events 16 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.0%
4/100 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Aortic Valve Stenosis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Mitral Valve Regurgitation/Mitral Insufficiency
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve- Perivalvular Leak
|
5.5%
21/381 • Number of events 21 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.2%
8/369 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Valve-Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Tricuspid Valve
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
5/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Skin and subcutaneous tissue disorders
General-Dermatogical
|
1.6%
6/381 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
11/369 • Number of events 12 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Dental Disorders
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Nose and Paranasal Sinuses
|
1.8%
7/381 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Throat
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
Disorders of Carbohydrate Metabolism
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
General- Fluid, Electrolyte, Endocrine and Metabolic Disorders
|
6.8%
26/381 • Number of events 34 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.9%
18/369 • Number of events 22 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Metabolism and nutrition disorders
Thyroid Disorders
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Diverticulitis
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Esophageal Disorders
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
General
|
2.6%
10/381 • Number of events 13 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.7%
10/369 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
General- Gastrointestinal Symptoms
|
1.0%
4/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Gastrointestinal disorders
Hepatic and Biliary Disorders
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
General- Genitourinary Disorders
|
9.2%
35/381 • Number of events 40 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
11.1%
41/369 • Number of events 42 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
6.0%
6/100 • Number of events 6 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
General- Genitourinary Symptoms
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.54%
2/369 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Myoneurogenic Disorders
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Prostate Disease
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Renal Failure
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Renal and urinary disorders
Urinary Tract Infections
|
8.7%
33/381 • Number of events 36 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.4%
20/369 • Number of events 21 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Blood and lymphatic system disorders
Anemias
|
12.1%
46/381 • Number of events 48 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
10.8%
40/369 • Number of events 40 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
11.0%
11/100 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Blood and lymphatic system disorders
General- Hematology and Oncology
|
22.8%
87/381 • Number of events 105 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
15.2%
56/369 • Number of events 65 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
17.0%
17/100 • Number of events 18 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Infections and infestations
Fungal Infections
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Infections and infestations
General- Infections
|
1.3%
5/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Infections and infestations
Viral
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.4%
5/369 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
Allergy
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Device Malposition or Malfunction
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Device Migration
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Product Issues
Thrombus on Device
|
2.9%
11/381 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.0%
11/369 • Number of events 11 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
General disorders
General-Miscellaneous
|
22.8%
87/381 • Number of events 111 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
18.4%
68/369 • Number of events 81 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
9.0%
9/100 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
Achilles Tendon Tear
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.0%
4/381 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.9%
7/369 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
General
|
1.8%
7/381 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.6%
6/369 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Musculoskeletal and connective tissue disorders
General- Musculoskeletal Symptoms
|
3.1%
12/381 • Number of events 15 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.2%
8/369 • Number of events 9 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
General-Neurological
|
6.8%
26/381 • Number of events 28 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.1%
19/369 • Number of events 19 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
General- Neurological Symptoms
|
6.6%
25/381 • Number of events 26 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.5%
13/369 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.0%
4/100 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Hemorrhage
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Acute Subdural Hematoma
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Nervous system disorders
Stroke
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Eye disorders
General- Opthalmologic Disorders
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Eye disorders
General- Opthalmic Symptoms
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.1%
4/369 • Number of events 4 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airway Disorders
|
1.3%
5/381 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.81%
3/369 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
General- Pulmonary/Respiratory Disorders
|
7.1%
27/381 • Number of events 29 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
4.1%
15/369 • Number of events 15 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
5.0%
5/100 • Number of events 5 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorders
|
3.4%
13/381 • Number of events 13 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
3.5%
13/369 • Number of events 14 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.1%
8/381 • Number of events 8 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.9%
7/369 • Number of events 7 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Respiratory, thoracic and mediastinal disorders
X-ray Finding
|
0.79%
3/381 • Number of events 3 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Bleeding
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
2.0%
2/100 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Hematoma
|
0.52%
2/381 • Number of events 2 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
1.0%
1/100 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Irreversible Nerve Damage
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Pain
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Pseudoaneurysm
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/369 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vessel Dissection
|
0.26%
1/381 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
|
Injury, poisoning and procedural complications
VASC Vessel Stenosis
|
0.00%
0/381 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.27%
1/369 • Number of events 1 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
0.00%
0/100 • Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days
Site-reported Serious and Other (Not Including Serious) Adverse Events reflect data collected from the intention-to-treat population (RCT) or enrolled analysis population (FlexNav Delivery System Study); while All-Cause Mortality reflects the entire population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place