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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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OSB Lead-Aorfix Post Approval Study

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Study Status Terminated
Application Number P110032 / PAS001
Date Current Protocol Accepted 11/01/2013
Study Name OSB Lead-Aorfix Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective observational study with a historical control, including both prospective follow-up of newly enrolled subjects, plus continued follow-up of the premarket cohort.
Study Population Description The study will include 234 prospectively enrolled subjects treated in accordance with the IFU for the device plus all 221 Aorfix¿ subjects enrolled into Lombard Medical¿s IDE study.
Sample Size 455 subjects, including 234 newly enrolled subjects plus 221 from the premarket cohort.

A minimum of 20 sites

Data Collection  Aneurysm-related mortality at 5 years (primary endpoint)

 Major adverse events at 30 days, and annually through 5 years

 Type I and III endoleaks

 Device migration

 Fracture in fixation zone

 Conversion to open surgery

 Change in aneurysm size

 Aneurysm rupture

Follow-up Visits and Length of Follow-up 5 years

30 day post-implant, one year, and annually thereafter

OSB Lead-Aorfix Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/15/2013 11/27/2013 Overdue/Received
one year report 02/14/2014 03/14/2014 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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