f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

FI-PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number /
Requirement Number		 P080025 / PAS001
Date Original Protocol Accepted 03/14/2011
Date Current Protocol Accepted 03/14/2011
Study Name FI-PAS
Device Name MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
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 Objectives Prospective, non-randomized, multicenter study
Study Population 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 120
Actual Number of Sites Enrolled 13
Patient 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)
Final 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
Final 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
Study 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.
Recommendations for Labeling Changes yes


FI-PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
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
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-