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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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HDE Post-Approval Study

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Study Status Completed
Application Number /
Requirement Number
H130006 / PAS001
Date Original Protocol Accepted 12/18/2015
Date Current Protocol Accepted  
Study Name HDE Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a follow on study, to the original set of subjects used for the approval of this HDE. The study is a multi-center, prospective, single-arm study in the United States and Europe of subjects with FI. Thirty-five subjects were implanted with the FENIX device in the U.S. (n=15) and Europe (n=20) prior to HDE approval. A total of 24 subjects continue to be enrolled for the extended follow-up period and will be prospectively followed to 5 years after the implant procedure.
Study Population Subjects (male or female) seeking surgical intervention for fecal incontinence who provided informed consent and met the study inclusion / exclusion criteria were eligible for this study
Sample Size 35 patients implanted. Only 24 patients remain at 60 months.
Key Study Endpoints There are no statistically derived endpoints for this feasibility study.

Bowel Diary
• Proportion of study patients achieving at least 50% reduction in FI episodes per week from baseline at 6, 12, 24, 36, 48, and 60 months.
• Proportion of study patients achieving at least 50% reduction in FI days per week from baseline at 6, 12, 24, 36, 48, and 60 months.

Fecal Incontinence Quality of Life (FIQOL)
• Proportion of study patients with improvement in FIQOL score. The four scales of the FIQOL instrument will be analyzed separately (Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment)

Characterized by the adverse events (AEs) experienced with the use of the FENIX
System and summarized as incidence rates. Serious device and procedure- related AEs will be summarized separately. Safety was also characterized by physical examination and pelvic X-ray.
Follow-up Visits and Length of Follow-up 5 years
12, 24,36, 48 and 60 months post implant
Interim or Final Data Summary
Actual Number of Patients Enrolled 43 (35 patients implanted)
Actual Number of Sites Enrolled 4
Patient Follow-up Rate The follow up rate at the different time points is shown below.
43 subjects enrolled
35 subjects implanted
100% (28/28) subjects attended the 1 year follow up visit.
6 subjects were explanted prior to 1 year and 1 exited lost to follow up (LTF)
96.3% (26/27) subjects attended the 2 year follow up visit.
One subject completed requirements, bringing the expected to (27) and 1 visit was missed, making the number of visits completed to 26, or 96.3%
100% (24/24) subjects attende
Final Safety Findings As shown in Table 43 from the submission, from the 223 AEs reported, there were 30 AEs that were related (or the relationship was unknown) to the device and/or procedure. These were tallied as follows:
Impaction or defecatory disorder (8)
Pain (5)
Bleeding (3)
Device Erosion (4)
Infection (4)
Other (6)
Mild Perineal bleeding
Mild Rectal Pain
Mild and Moderate Constipation
Mild Anal Pain
Moderate Allergy, inflammation reaction

Final Effect Findings The sponsor presents data showing the percent reduction in FI episodes per week. Appendix A (page 7 of 77)
shows that:
9.1% (2/22) showed no response, at 60 months
91% (20/22) had a greater than 25% decrease in FI episodes at 60 months
73% (16/22) had a greater than 50% decrease in FI episodes at 60 months
64% (14/22) had a greater than 75% decrease in FI episodes at 60 months
32% (7/22) had a 100% decrease in FI episodes at 60 months
Study Strengths & Weaknesses Length of follow up was 5 years
Patients were assessed for safety and efficacy (although the requirement is “probable benefit”).
73% (16/22) had a greater than 50% decrease in FI episodes at 60 months
32% (7/22) had a 100% decrease in FI episodes at 60 months

Study Weaknesses
This was a single arm a study without a comparator
High degree of patient loss by 60 months. 35 patients were implanted, and 24 were left at the end of 60 months. 23-35 = 11. 11/35 = 31% of patients were lost.
Recommendations for Labeling Changes Labeling change is recommended to reflect the methods and long term data results obtained from PAS
All PAS results tables should be included (existing from the approval order)
Inclusion of ODS scores, for patients that had an increase in impaction disorder
Statement about FIQOL scores for these patients

HDE Post-Approval Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
final report 06/17/2016 06/16/2016 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources