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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-INTERMACS Companion


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General
Study Status Progress Adequate
Application Number P030011 S011/ PAS002
Date Current Protocol Accepted 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).
Interim or Final Data Summary
Interim Safety Information Number of study sites enrolled As of December 31, 2016, 50 INTERMACS Sites have registered at least one patient

Number of subjects enrolled As of December 31, 2016 200 C2 Driver and 88 CSS Console Users were enrolled

Follow-up rate As of December 31, 2016 Approximately 100 percent

Summary of Interim Results Included Interim Results summarize mortality and neurologic adverse events across both arms of the study up to December 31, 2016.

Mortality: FDA first communicated about interim PAS results in a June 15, 2015 letter to health care providers to inform the health care community about a higher three month mortality rate for the subgroup of patients requiring pre implant circulatory rescue interventions when using SynCardia's C2 Driver System (60 percent) compared to the mortality rate for those patients requiring pre implant circulatory rescue interventions when using the SynCardia CSS Console (17 percent). For the subgroup of patients who did not require pre implant circulatory rescue interventions, mortality rates were similar (16 percent for C2 Driver System users vs. 15 percent for CSS Console users).

In an updated letter to health care providers dated October 26, 2016, FDA communicated that the three-month mortality rate for this subgroup of patients requiring pre implant circulatory rescue interventions was still higher for those supported initially by the C2 Driver system (39 percent) compared to those initially supported by the CSS Console (25 percent). For the subgroup of patients who did not require pre implant circulatory rescue interventions, three- month mortality rates were again similar (16 percent for C2 Driver System users vs. 15 percent for CSS Console users).

The most recent data from the manufacturer’s 42 month interim report continues to indicate that the three month mortality rate for the subgroup requiring pre implant circulatory rescue intervention is higher for those patients initially supported by the C2 Driver (42 percent) compared to those initially supported by the CSS Console (21 percent). But the three month mortality rates are similar for those patients who did not require pre implant circulatory rescue intervention (30 percent for C2 Driver System users vs. 24 percent for CSS Console users). The final report is due in December 2017.



Neurologic Dysfunction Adverse Events Rate: In the October 2016 letter to health care providers, FDA communicated that there was also a higher three month rate of neurologic adverse events (NAE) for patients initially supported by SynCardia’s C2 Driver System (31 percent) compared to those patients initially supported by the SynCardia CSS Console (16 percent; p value equal to 0.02). This difference persists in the most recent data from the 42 month interim report (31 percent for those initially supported by the C2 Driver System users vs. 14 percent for CSS Console, p less than 0.0001). This difference appears to be driven mainly by the rate of cerebrovascular accident for the two groups (27 percent for those initially supported by the C2 Driver System users vs. 8 percent for those initially supported by the CSS Console, p value less than 0.0001). Differences between the two groups regarding other NAEs were not statistically significant.

At the time of the October letter to providers, NAE results were not stratified by pre implant circulatory rescue intervention status. Subgroup analyses of the 42 month report data by pre implant circulatory rescue intervention status does not show a difference in the NAE rate based upon pre implant circulatory rescue interventions.



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 12/23/2016 On Time
42 month report 07/10/2017 07/10/2017 On Time
final report 12/24/2017    


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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