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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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AAA Flex 36mm

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Study Status Completed
Application Number P020018 S010/ PAS001
Date Current Protocol Accepted 09/07/2006
Study Name AAA Flex 36mm
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Australian study is a multi-center, non-randomized prospective clinical study, with six Australian sites participating. The U.S. physician sponsored pre market study is a single center, non-randomized retrospective study. The plan is to assess patients from both studies for a total duration of five years.
Study Population Description Patients who were implanted with the device in the original study, with an abdominal aortic aneurysm or aortic-ileac aneurysm of at least 5 cm or expanding at a rate of at least 0.5 cm per year, who does not meet the study's exclusion criteria.
Sample Size 15 Austrailian and 26 US patients
Data Collection Endpoints include: 1) adverse events, 2) endoleaks, 3) secondary interventions, 4) aneurysm enlargement, 5) rupture, 6) conversion, and 7) aneurysm-related death.
Follow-up Visits and Length of Follow-up Length of follow-up is five years. Patients will be followed on an annual basis.
Interim or Final Data Summary
Interim Safety Information The size of the postapproval study making the power of the study to detect a high rate of aneurysm-related deaths low. However, the consensus of the FDA review team is that the confidence in the safety and effectiveness of this device is high because the only modification from the previous approved device is an enlargement of the size. Furthermore, the study was approved with full knowledge that the sample size would be small, no aneurysm-related deaths have been reported to this date, and because the device is rarely used it would be very difficult to recruit substantial new cases at this time.
Actual Number of Patients Enrolled 41
Actual Number of Sites Enrolled 8
Patient Follow-up Rate 18% through five years
Final Safety Findings There were no aneurysm-related deaths or conversions to open surgery. There was one ruptured aneurysm which occurred within the first year post implant..
Final Effect Findings There were no cases of device migration, and aneurysms were far more likely to shrink than grow in size during the course of the study.
Study Strengths & Weaknesses Follow-up rate was very poor. That plus the fact that the study was very small to begin with means that the data were too sparse to make any definitive conclusions.
Recommendations for Labeling Changes None. The data from this study do not change current knowledge of device performance

AAA Flex 36mm Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 09/07/2007 10/11/2007 Overdue/Received
2 year report 09/08/2008 09/08/2008 On Time
3 year report 09/06/2009 09/03/2009 On Time
4 year report 09/06/2010 09/07/2010 Overdue/Received
5 year report-Final Report 09/06/2011 09/02/2011 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

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

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