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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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Study Status Other
Application Number P070005 / PAS001
Date Current Protocol Accepted 03/06/2009
Study Name REPEL CV
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, comparative, randomized study of REPEL-CV in pediatric patients (<21 years of age) undergoing cardiac procedures via sternotomy. The patient will be randomized to either treatment with REPEL-CV or no adhesion barrier.
Study Population Description The population will be pediatric (<21 years of age) patients who are greater than 48 hours of age, requiring a first cardiovascular sternotomy procedure, on cardiopulmonary bypass and without delayed chest closure.
Sample Size 640 patients randomized and treated with either REPEL-CV (320 patients) or the untreated study-directed control (320 patients), 15 sites
Data Collection The primary safety endpoint will be the incidence of a composite measure based on the patient-level incidence of the following two specific adverse events: 1) Re-operation for re-bleeding and/or cardiac tamponade; 2) Mediastinitis: defined as a deep sternal infection. The secondary safety endpoints will be: 1) The individual incidence of re-operation for re-bleeding and/or tamponade, and mediastinitis; 2) The specific incidence of mediastinitis, delayed constrictive pericarditis, sternal non-union, sternal dehiscence, and reoperation for bleeding and/or tamponade.
Follow-up Visits and Length of Follow-up Patients will be followed for 6 months post initial sternotomy. However, patients who undergo a planned (staged) second sternotomy (not to include: emergent re-entry, or mediastinitis, or re-operation for re-bleeding and/or tamponade) within 6 months of the first sternotomy will be followed for 3 months post the planned second sternotomy.

REPEL CV Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 02/08/2010 02/05/2010 On Time
1 Year report 03/06/2010 03/03/2010 On Time
18 month report 09/04/2010 12/10/2010 Overdue/Received
2 year report 03/06/2011 03/07/2011 Overdue/Received
30 month report 09/14/2011 09/14/2011 On Time
3 year report 03/06/2012 03/07/2012 Overdue/Received
42 month report 09/06/2012 09/05/2012 On Time
48 month report 03/16/2013 06/14/2013 Overdue/Received
54 month report 09/14/2013 09/10/2013 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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