Trial Outcomes & Findings for Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP® (NCT NCT00534092)

NCT ID: NCT00534092

Last Updated: 2021-01-05

Results Overview

Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.

• Recruitment status: COMPLETED
• Target enrollment: 69 participants
• Primary outcome timeframe: 3+ years following first 2 years post-X-STOP implant through IDE study
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	Target Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
Overall Study STARTED	55	14
Overall Study COMPLETED	53	14
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Target Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
Overall Study Lost to Follow-up	1	0
Overall Study personal reasons/family concerns	1	0

Baseline Characteristics

Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

Baseline characteristics by cohort

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	76.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	72.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	6 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian / Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	46 participants n=5 Participants	12 participants n=7 Participants	58 participants n=5 Participants
Race/Ethnicity, Customized Unknown	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 3+ years following first 2 years post-X-STOP implant through IDE study

Population: Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.

Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.

Outcome measures

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total patients included target group and safety group.
Treatment Success Rates (At ≥ 5 Years) Treatment success rate (n=49, 13, 62)	40.8 percentage of participants	30.8 percentage of participants	38.7 percentage of participants
Treatment Success Rates (At ≥ 5 Years) SS improved >=0.5 point (n=52, 13, 65)	53.8 percentage of participants	84.6 percentage of participants	60.0 percentage of participants
Treatment Success Rates (At ≥ 5 Years) PF improved >=0.5 point (n=52, 14, 66)	73.1 percentage of participants	50.0 percentage of participants	68.2 percentage of participants
Treatment Success Rates (At ≥ 5 Years) PS Score <2.5 (n=53, 14, 67)	81.1 percentage of participants	92.9 percentage of participants	83.6 percentage of participants
Treatment Success Rates (At ≥ 5 Years) No device-related complication (n=53, 14, 67)	94.3 percentage of participants	100.0 percentage of participants	92.5 percentage of participants
Treatment Success Rates (At ≥ 5 Years) No additional surgery at index level(n=53, 14, 67)	94.3 percentage of participants	100.0 percentage of participants	95.5 percentage of participants
Treatment Success Rates (At ≥ 5 Years) Maintenance of distraction (n=42, 11, 53)	95.2 percentage of participants	90.9 percentage of participants	94.3 percentage of participants
Treatment Success Rates (At ≥ 5 Years) No dislodgement of implant (n=43, 11, 54)	100.0 percentage of participants	81.8 percentage of participants	96.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.

Outcome measures

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total patients included target group and safety group.
Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) Mean Change in SS (n=52, 13, 65)	-0.8 units on a scale Standard Deviation 0.9	-1.0 units on a scale Standard Deviation 0.5	-0.8 units on a scale Standard Deviation 0.8
Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) Mean change in PF (n=52, 14, 66)	-1.0 units on a scale Standard Deviation 0.7	-0.4 units on a scale Standard Deviation 0.4	-0.8 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3+ years following first 2 years post-X-STOP implant through IDE study

ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.

Outcome measures

Measure	Target n=53 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=67 Participants Total patients included target group and safety group.
Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)	1.7 units on a scale Standard Deviation 0.8	1.5 units on a scale Standard Deviation 0.6	1.6 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.

Outcome measures

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total patients included target group and safety group.
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) General Health (n=52, 14, 66)	-5.4 units on a scale Standard Deviation 14.1	-0.9 units on a scale Standard Deviation 11.4	-4.2 units on a scale Standard Deviation 13.6
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) PCS (n=49, 13, 62)	8.6 units on a scale Standard Deviation 10.4	11.6 units on a scale Standard Deviation 9.2	9.2 units on a scale Standard Deviation 10.2
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Vitality (n=52, 14, 66)	7.9 units on a scale Standard Deviation 25.2	10.0 units on a scale Standard Deviation 14.3	8.3 units on a scale Standard Deviation 23.3
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Bodily Pain (n=52, 14, 66)	23.4 units on a scale Standard Deviation 26.2	31.1 units on a scale Standard Deviation 19.9	25.0 units on a scale Standard Deviation 25.1
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) MCS (n=49, 13, 62)	3.9 units on a scale Standard Deviation 12.6	2.7 units on a scale Standard Deviation 8.9	3.7 units on a scale Standard Deviation 11.9
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Mental Health (n=52, 14, 66)	3.8 units on a scale Standard Deviation 19.5	3.4 units on a scale Standard Deviation 10.9	3.7 units on a scale Standard Deviation 17.9
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Physical Functioning (n=52, 14, 66)	28.0 units on a scale Standard Deviation 30.0	27.1 units on a scale Standard Deviation 15.9	27.8 units on a scale Standard Deviation 27.5
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Role-Emotional (n=50, 13, 63)	24.0 units on a scale Standard Deviation 58.7	35.9 units on a scale Standard Deviation 44.0	26.5 units on a scale Standard Deviation 55.9
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Role-Physical (n=50, 14, 64)	28.5 units on a scale Standard Deviation 51.8	50.0 units on a scale Standard Deviation 42.7	33.2 units on a scale Standard Deviation 50.4
Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) Social Functioning (n=52, 14, 66)	32.0 units on a scale Standard Deviation 34.9	15.2 units on a scale Standard Deviation 23.1	28.4 units on a scale Standard Deviation 33.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3+ years following first 2 years post-X-STOP implant through IDE study

The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.

Outcome measures

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total patients included target group and safety group.
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with Re-operations	0 participants	0 participants	0 participants
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with Subsequent surgeries	5 participants	1 participants	6 participants
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with Revision	2 participants	0 participants	2 participants
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with Removal	3 participants	0 participants	3 participants
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with Supplemental Fixations	0 participants	0 participants	0 participants
Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study Number of Patients with other subsequent surgeries	2 participants	1 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3+ years following first 2 years post-X-STOP implant through IDE study

Outcome measures

Measure	Target n=55 Participants Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 Participants Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 Participants Total patients included target group and safety group.
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study Undetermined	3 participants	0 participants	3 participants
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study Not related	15 participants	5 participants	20 participants
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study Implant related	0 participants	0 participants	0 participants
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study Procedure related	1 participants	0 participants	1 participants
Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study Implant & Procedure related	2 participants	0 participants	2 participants

Adverse Events

Target

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

Safety

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Total

Serious events: 15 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	Target n=55 participants at risk Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 participants at risk Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 participants at risk Total patients included target group and safety group.
General disorders Device failure	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders Hypertrophy	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders Periprosthetic fracture	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders Device deployment issue	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders Inguinal hernia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders Device dislocation	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications Wound dehiscence	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures Hip arthroplasty	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Blood and lymphatic system disorders Anaemia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders Varices oesophageal	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders Hydrocephalus	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders Spinal claudication	5.5% 3/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures Cardiac pacemaker insertion	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures Hip surgery	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures Intervertebral disc operation	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.

Other adverse events

Measure	Target n=55 participants at risk Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).	Safety n=14 participants at risk Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.	Total n=69 participants at risk Total patients included target group and safety group.
Psychiatric disorders depressive symptom	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Psychiatric disorders insomnia	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Renal and urinary disorders incontinence	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Renal and urinary disorders pollakiuria	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Renal and urinary disorders proteinuria	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Reproductive system and breast disorders benign prostatic hyperplasia	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	5.8% 4/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Reproductive system and breast disorders prostatomegaly	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders dyspnoea	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders emphysema	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders rhinitis allergic	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Respiratory, thoracic and mediastinal disorders sleep apnoea syndrome	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Skin and subcutaneous tissue disorders erythema nodosum	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Skin and subcutaneous tissue disorders night sweats	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures bladder repair	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures cholecystectomy	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures corneal transplant	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures hip arthroplasty	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures injection	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures knee arthroplasty	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures knee operation	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures partial lung resection	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures spinal operation	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures stent placement	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Surgical and medical procedures wound treatment	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders aortic aneurysm	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders deep vein thrombosis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders hot flush	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders hypertension	10.9% 6/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	10.1% 7/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders intermittent claudication	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders peripheral artery aneurysm	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders phlebitis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Vascular disorders varicose vein	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders transient ischaemic attack	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Cardiac disorders arrhythmia	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Cardiac disorders atrial fibrillation	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Cardiac disorders coronary artery disease	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Cardiac disorders myocardial infarction	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Congenital, familial and genetic disorders factor v leiden mutation	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Ear and labyrinth disorders deafness neurosensory	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Ear and labyrinth disorders hypoacusis	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Endocrine disorders acromegaly	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Endocrine disorders thyroid disorder	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Eye disorders cataract	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Eye disorders glaucoma	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Eye disorders macular degeneration	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders constipation	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders dysphagia	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders gastrointestinal haemorrhage	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders gastrooesophageal reflux disease	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	28.6% 4/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	8.7% 6/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders haemorrhoids	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders inguinal hernia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders nausea	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders oesophageal stenosis	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Gastrointestinal disorders vomiting	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders asthenia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders chills	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders drug withdrawal syndrome	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders fatigue	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders feeling abnormal	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders hernia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders oedema peripheral	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders pain	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
General disorders polyp	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Immune system disorders multiple allergies	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	21.4% 3/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations bronchitis	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations cellulitis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations cystitis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations influenza	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations pneumonia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations upper respiratory tract infection	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Infections and infestations urinary tract infection	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications ankle fracture	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications clavicle fracture	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications contusion	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications excoriation	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications fall	10.9% 6/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	8.7% 6/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications femur fracture	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications ligament rupture	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications lumbar vertebral fracture	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications pelvic fracture	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications post-traumatic pain	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications road traffic accident	5.5% 3/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	5.8% 4/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications spinal fracture	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications upper limb fracture	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Injury, poisoning and procedural complications wound complication	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Investigations pedal pulse decreased	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Metabolism and nutrition disorders diabetes mellitus	5.5% 3/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Metabolism and nutrition disorders gout	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Metabolism and nutrition disorders hyperlipidaemia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Metabolism and nutrition disorders hypocholesterolaemia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Metabolism and nutrition disorders type 2 diabetes mellitus	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders arthralgia	16.4% 9/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	13.0% 9/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders arthritis	7.3% 4/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	8.7% 6/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders arthropathy	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders back disorder	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders back pain	23.6% 13/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	21.7% 15/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders bursitis	5.5% 3/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders cervical spinal stenosis	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders intervertebral disc degeneration	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders intervertebral disc disorder	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders intervertebral disc protrusion	7.3% 4/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	5.8% 4/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders limb discomfort	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders lumbar spinal stenosis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders muscle spasms	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders muscle tightness	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders musculoskeletal discomfort	0.00% 0/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders musculoskeletal pain	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	14.3% 2/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	5.8% 4/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders myalgia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders neck pain	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders osteoarthritis	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders pain in extremity	9.1% 5/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.2% 5/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders polychondritis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders rotator cuff syndrome	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders scoliosis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders spinal osteoarthritis	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Musculoskeletal and connective tissue disorders tendon pain	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung neoplasm malignant	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant neoplasm of eye	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) multiple myeloma	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pituitary tumor benign	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) prostate cancer	5.5% 3/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders amnesia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders ataxia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders carotid artery stenosis	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders carpal tunnel syndrome	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders cerebrovascular accident	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders cognitive disorder	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders cubital tunnel syndrome	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders headache	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders hypoaesthesia	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders neuropathy peripheral	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders occipital neuralgia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders parkinson's disease	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders peroneal nerve palsy	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders radicular pain	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders sciatica	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	2.9% 2/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders spinal claudication	7.3% 4/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	5.8% 4/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Nervous system disorders vascular dementia	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Psychiatric disorders anxiety	1.8% 1/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	0.00% 0/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	1.4% 1/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Psychiatric disorders depression	3.6% 2/55 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	7.1% 1/14 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.	4.3% 3/69 • 3+ years following first 2 years post-X-STOP implant through IDE study An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.

Additional Information

Clinical Department

Medtronic Spine and Biologics

Phone: 1800-876-3133

Email: msbkclinicalresearch@medtronic.com

Results disclosure agreements

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

Restriction type: OTHER