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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Application Number P080025 / PAS001
Current Plan Approved 03/14/2011
Study Name FI-PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, multicenter study
Study Population Description Study subjects are individuals enrolled in IDE study with a history of chronic fecal incontinence who failed or were not candidates for more conservative treatments. Subjects serve as self controls.
Sample Size 285 subjects, 12 sites
Follow-up Visits and Length of Follow-up 5 years post implant

Yearly up until at least 5 years post implant

Final Study Results
Number of Patients 120
Number of Sites 13
Follow-up Rate 60% (72/120)(Rate included 14 subjects who were lost due to death of Principal Investigator and

5 died of causes unrelated to the device or therapy)

Safety Findings There were no specific study safety endpoints in this post approval study. Safety was monitored in a purely descriptive fashion. There were 21 serious device/therapy related adverse events and

351 non-serious device or therapy related adverse events, many of which required surgical intervention.

Over the course of the study that there were 10 device revisions among 10 subjects, 40 device replacements among 29 subjects and 22 device explants among 22 subjects. The overall device revision and replacement rate was 24.4%, and the overall device explantation rate was 19%. The all cause surgical intervention rate for the 120 enrolled subjects was 35.6% for the first 5 years

Effect Findings Primary Endpoint: Incontinent Episoides ( ¡Ý50% improvement from baseline): Proportion of Successes: 69% (95%CI- 60%-77%), based on last observation carried forward imputation method for missing subjects
Strengths & Weaknesses Strength: Prospective hypothesis driven study, high level of quality control, multiple effectiveness outcomes evaluated including patient centered disease specific QoL questionnaires.

Weakness: High loss to follow-up, no study safety hypothesis.
Label Changes yes

FI-PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/12/2011 09/15/2011 Overdue/Received
one year report-final report 04/12/2012 04/13/2012 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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