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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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OSB Lead-Long Term

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Application Number P860057 S029/ PAS001
Current Plan Approved 01/24/2014
Study Name OSB Lead-Long Term
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, single-arm, multi-center study that will enroll a

minimum of 250 patients implanted with the Carpentier-Edwards PERIMOUNT 7000 TFX, 72000 TFX and 73000 TFX, Magna Ease, Model 3300TFX, in order to achieve 101/Aortic valve replacement subjects each followed for a minimum of 8 years.

A new enrollment study.

Study Population Description Study Population: Patients must be at least 18 years of age

eligible for mitral valve replacement. Indication: It is intended for patients who require replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and whose prognosis without aortic valve replacement is unacceptably poor.

No comparator group.
Sample Size A minimum of 250/Subjects at up to 25/Sites in order to obtain a

minimum of 8 years data on 101 subjects.

Data Collection Endpoints include thrombo-embolism, perivascular leak,

hemorrhage, endocarditis, and heart failure. Early AE (within 30 days of implant) are summarized as the percent (events

/subjects) of subjects experiencing an early event. Late post- operative AE (>30 days post-implant) are summarized in terms of linearized rates (events /patient years).

Follow-up Visits and Length of Follow-up 8 years - Patients will be followed at discharge, 6-months, one year, and annually thereafter for a minimum of 8 years.
Final Study Results
Interim Safety Information The 30-day mortality rate is not statistically different than that reported in the medical literature.

OSB Lead-Long Term Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/02/2009 03/02/2009 On Time
1 year report 08/29/2009 08/27/2009 On Time
18 month report 02/27/2010 02/23/2010 On Time
2 year report 08/29/2010 08/19/2010 On Time
3 year report 08/29/2011 08/29/2011 On Time
4 year report 08/28/2012 08/13/2012 On Time
5 year report 08/28/2013 09/11/2013 Overdue/Received
Correction to Info on 4 Year Report 08/30/2013 08/28/2013 On Time
6 year report 08/28/2014 08/27/2014 On Time
7 year report 08/28/2015 08/26/2015 On Time
8 year report 08/27/2016 08/26/2016 On Time
9 year report 08/27/2017    

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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