f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Clinical Study


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General
Study Status Completed
Application Number /
Requirement Number		 P860057 S042/ PAS001
Date Original Protocol Accepted 11/03/2009
Date Current Protocol Accepted 11/03/2009
Study Name Clinical Study
Device Name CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
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
Interim or Final Data Summary
Actual Number of Patients Enrolled 258
Actual Number of Sites Enrolled 14
Patient Follow-up Rate 98%
For the 258 patients implanted with the Magna Ease aortic valve, mean follow-up was 6.2 ± 2.4 years, range of follow-up was 0 – 8.2 years, and total cumulative follow-up was 1597.6 patient-years. There were 1576.6 late patient-years of follow-up for the implanted patients.
Final Safety Findings The study device was found to meet all Objective Performance Criteria with the exception of Bleeding (All and Major) in which the upper 95% confidence limit was above 2xOPC (3.4 vs 2.8 for All Bleeding and 1.9 vs 1.8 for Major Bleed). This results are acceptable when considering the cause of bleed for affected patients. The Kaplan-Meier rate for Freedom from Structural Valve Deterioration (SVD) was 90.1% at 8 years.
Final Effect Findings At all follow-up timepoints out to 8 years 93.9% of patients were NYHA Class I or Class II. At 8 years, 88.6% of patients had trivial or none regurgitation and 10.2% of patients had mild regurgitation. No patients were reported with severe regurgitation at any timepoint. Of patients that had regurgitation, most were central regurgitation rather than perivalvular.
Study Strengths & Weaknesses Strengths of the study included the overall follow-up of patients through mid-term durations (8 years) to collect 1576.6 late patient-years of follow-up for the implanted patients.
Weaknesses of the study include that the study was a single-arm trial which is true for most recent surgical valve studies. Additionally, the final dataset was limited by missing echocardiograms for various timepoints throughout the study.
Recommendations for Labeling Changes The sponsor should update their labeling to reflect the results obtained in the completed study.


Clinical Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/05/2010 08/04/2010 On Time
1 year report 11/05/2010 11/02/2010 On Time
18 month report 05/07/2011 05/09/2011 Overdue/Received
2 year report 11/05/2011 11/04/2011 On Time
3 year report 08/04/2012 08/01/2012 On Time
4 year report 05/06/2013 06/25/2013 Overdue/Received
5 year report 05/06/2014 05/05/2014 On Time
6 year report 05/06/2015 04/30/2015 On Time
7 year report 05/05/2016 05/02/2016 On Time
8 year report 05/05/2017 05/01/2017 On Time
Final Report 11/30/2018 11/29/2018 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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