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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-Biocor & Biocor Supra Valves

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Study Status Completed
Application Number P040021 / PAS001
Date Current Protocol Accepted 08/30/2012
Study Name OSB Lead-Biocor & Biocor Supra Valves
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort
Study Population Description Subjects requiring an aortic valve replacement were implanted with either the Biocor aortic valve or the Biocor Supra aortic valve

Sample Size A total of 800 patient- years of follow-up with a minimum of 100 patients followed for at least 5 years, enrolled across 25 sites.
Data Collection NYHA, hemolysis, nonstructural dysfunction, paravalvular leak, structural deterioration/failure, bleeding events, embolism, endocarditis, valve thrombosis, reoperation, explant and death (all and valve-related).
Follow-up Visits and Length of Follow-up >120 patients would be out 4 years or more, -50-70 patients will be out 6 years or more and of these 25-30 would be out 7 years.

Annually out to 8 years

Interim or Final Data Summary
Interim Safety Information At one year the majority of subjects report none or trivial hemodynamic insufficiency. There were no mean gradients greater than 14.9 mmHg reported.
Actual Number of Patients Enrolled 300 (297 subjects met eligibility criteria)
Actual Number of Sites Enrolled 17
Patient Follow-up Rate at 5 years (114 eligible subjects) - 94.7% (108/114)

Overall cumulative follow-up - 959.4 late patient-years (average of 3.2± 1.9 years)

Final Safety Findings Early adverse event rate (? 30 days post implant) based on 297 subjects:

Bleeds 7.4% (7.1% major), Deaths 2.4% (0.3% valve-related), Embolism 0.7%, and 0.3% Paravalvular leak.

Linearized late adverse event rate (number per 100 late patient year) based on 959.4 late patient years are as follows:

Bleeds 4.48 (4.17 major), Deaths 3.86 (0.52 valve-related), Reoperation 1.36, Endocarditis 1.04, Embolism 0.83 (TIA 0.52, stroke 0.10), Nonstructural dysfunction 0.42, Structural deterioration 0.31, and Thrombosis 0.10.

The rates of freedom from event at 5 years post implant by Kaplan Meier analysis are

Structural valve deterioration - 97.7% Reoperation- 94.2%

Valve-related mortality- 97.5% Bleeding Event ? 76.1% Embolism- 95.2%

Endocarditis- 96.1%

Final Effect Findings The proportion of subjects in NYHA class I or II at 5 years: all Biocor valve positions - 91.5% (97/106), Aortic position - 93.1% (41/44), Aortic Supra position - 90.9% (40/44) and Mitral position- 88.9% (16/18)
Study Strengths & Weaknesses The study achieved a high follow-up rate of 94.7% at 5-year post implant, and an overall follow-up of

959.4 late patient years greater than the expected 800 late patient years. At least 100 patients were

followed out to 5 years as required per protocol.


This was a single arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.

Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ?up visits etc.), final results and study strengths and limitations of the PAS.

OSB Lead-Biocor & Biocor Supra Valves Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 08/05/2006 09/11/2006 Overdue/Received
2 year report 08/05/2007 08/03/2007 On Time
3 year report 08/04/2008 08/04/2008 On Time
4 year report 08/04/2009 08/05/2009 Overdue/Received
5 year report 08/04/2010 07/29/2010 On Time
annual report 08/03/2011 08/03/2011 On Time
7 year report 08/03/2012 08/02/2012 On Time
8 year report 08/05/2013 07/29/2013 On Time
9 year report 08/05/2014 08/01/2014 On Time
10 year report 08/05/2015 08/05/2015 On Time
Final Report 12/01/2015 12/01/2015 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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