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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Postmarket Surveillance Registry


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General
Application Number P020018 S005/ PAS001
Current Plan Approved 06/09/2005
Study Name Postmarket Surveillance Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Renu registry was designed as a non-randomized, single arm, prospective, postmarket registry of cases involving the Zenith Renu AAA Ancillary Graft. The specific aims of the study are to1) obtain data on physician experience with the Zenith Renu AAA Ancillary Graft and 2 confirm device performance as measured by the absence of subsequent device-related problems.
Study Population Description The Zenith Renu AAA Ancillary Graft from Cook Incorporated is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aorto-iliac aneurysms. All cases entered into the registry will meet the following criteria: 1) Failed, existing non-Cook endograft, 2) Zenith Renu AAA Ancillary Graft, 3) Compliance with the intended use and implantation procedures described in the Renu IFU, 4) Registry data are de-identified with respect to patient.
Sample Size 100 patients, no site limit specified
Data Collection Endpoints include: 1) Post-procedure (within 30 days of the procedure) rate of rupture and subsequent death, 2) Post-procedure (within 30 days of the procedure) proximal attachment status (i.e., barb separation, stent fracture/breakage, position of the Zenith Renu AAA Ancillary Graft with respect to the fixation site and integrity of the seal with the aorta by the absence of a Type I endoleak as well as the pre-existing endovascular graft by the absence of a Type III endoleak), and 3) Post-procedure (within 30 days of the procedure) adverse events and re-interventions.
Follow-up Visits and Length of Follow-up Data will be collecte pre-procedure, post-procedure within 30 days, at 12 months with clinical and imaging follow-up, and telephone and imaging follow-up of adverse events and mortality annually up to five years.
Final Study Results
Interim Safety Information A low occurrence of deployment problems was reported. No problems were reported for over 90% of the cases in each deployment category. All 151 implanted Zenith Renu AAA Ancillary Grafts were deployed successfully (i.e., successful delivery and deployment of the device and successful removal of the delivery system). One hundred eleven (111) cases were identified with endoleaks prior to or during the procedure.

Of those cases with endoleak, 96 were proximal type I endoleaks. The vast majority of new endoleaks at follow-up have been identified as type II. The sponsor concludes that it is likely many had been previously overlooked, misidentified, or masked by other existing endoleaks during review at earlier time periods.
Number of Patients 151
Number of Sites 95
Follow-up Rate 60%
Safety Findings One case of Renu migration occurred at 36 months after implantation. One occlusion was identified at the 24-month time period.. Death beyond 30 days of the initial procedure occurred in 43 cases. Twenty-nine cases were determined to be unrelated to endovascular repair. Of the 14 remaining cases, 5 have been adjudicated as related to endovascular repair (i.e., procedure, technique, pre-existing graft, and/or Renu-related) and 9 are unable to be adjudicated due to insufficient information from the site (no additional information is able to be collected).
Effect Findings One hundred eleven (111) cases (73.5%) were identified with endoleaks prior to or during the procedure. Of those cases with endoleaks, 96 were proximal type I endoleaks. There were 26 new type II endoleaks at one month and one remained at 60 months.
Strengths & Weaknesses The sponsor reports that 91 patients reached an endpoint at 5 years. Although the follow-up rate therefore is only 60%, there are enough patients with 5 year endpoint information since the conditions only required 100 patients to be enrolled.. The study provides additional information that can be used for updated labeling.
Label Changes Yes. The labeling supplement should include a summary of the post-approval study design, results, and study strengths and limitations. In addition, sponsor should provide not only rates in the revised labeling, but reasons for secondary interventions and conversions, as well as contributing factors or causes of death. Finally, the labeling should highlight the endoleak data from the post-approval study.


Postmarket Surveillance Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month registry report 09/08/2005 11/17/2005 Overdue/Received
6 month registry report 12/08/2005 01/18/2006 On Time
9 month registry report 03/09/2006 04/10/2006 Overdue/Received
1 year registry report 06/09/2006 07/13/2006 Overdue/Received
15 month registry report 09/08/2006 10/10/2006 Overdue/Received
18 month report 12/08/2006 01/10/2007 Overdue/Received
2 year report 06/09/2007 06/07/2007 On Time
3 year report 06/08/2008 06/03/2008 On Time
4 year report 06/08/2009 06/04/2009 On Time
5 year report 06/08/2010 05/27/2010 On Time
Final report 02/28/2011 02/28/2011 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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