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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-INTERMACS Companion


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General
Application Number P030011 S011/ PAS002
Current Plan Approved 11/27/2015
Study Name OSB Lead-INTERMACS Companion
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a two armed (partially retrospective and partially prospective), multi center, non randomized, cohort registry study that uses the INTERMACS Registry to compare performance of the TAHt when supported with the Companion 2 Driver System vs. performance of the TAH쳌t when supported with the CSS Console.

The primary endpoint will be the comparison of the positive outcome rate for TAHt patients initially supported with the Companion 2 Driver System compared to the positive outcome rate for patients initially supported with the CSS Console (concurrent cohort). Positive outcome will be assessed at both three and six months post-implant, and is defined as transplant, transfer to Freedom Driver, or continuing on implant driver support. The hypothesis is that the C2 Driver is non-inferior in positive outcome rate to the CSS Console by a margin of 10 percentage points.”

“Secondary Objectives will be to provide descriptive statistics on enrollment, adverse events, and outcomes for all TAHt patients enrolled in the INTERMACS registry. Additionally, the positive outcome rate for all patients initially supported with the Companion 2 Driver System will be compared to the positive outcome rate of all patients initially supported with the CSS Console (cumulative cohort).

Study Population Description Patients in the INTERMACS Registry who are implanted with the TAH쳌t and used the C2 Driver System as their initial driver.

There will be 2 control groups used for comparison. One consists of all Patients in the INTERMACS Registry who are implanted with the TAH쳌t who used the CSS Console (cumulative cohort). The other consists only patients in the INTERMACS Registry who were implanted with the TAH쳌t after The C2 Driver System began to be used June 2012 (concurrent cohort).





Sample Size The study will be composed of 200 patients supported by the Companion 2 Driver System and all INTERMACS Registry patients supported by the CSS Console at the time that the sample size for the C2 Driver System reaches 200.
Data Collection The data will be collected as defined in the INTERMACS Protocol.

The primary endpoint of survival rate at 3 and 6 months post implant will be evaluated according to the hypothesis mentioned above. Secondary objectives include the analysis of the same hypothesis except the comparing the C2 Driver System to the cumulative CSS console cohort.

Follow-up Visits and Length of Follow-up 4 years

Per INTERMACS Registry (1 week, 1 month, 3 month, 6 month and every 6 months thereafter).


OSB Lead-INTERMACS Companion Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/24/2014 06/24/2014 On Time
one year report 02/11/2015 02/18/2015 Overdue/Received
18 month report 06/24/2015 06/24/2015 On Time
two year report 01/25/2016 01/27/2016 Overdue/Received
three year report 12/24/2016    
42 month report 06/24/2017    
four year report 12/24/2017    
54 month report 06/24/2018    
5 year report 12/24/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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