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TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results

[Posted 10/26/2016]

AUDIENCE: Cardiology, Surgery

ISSUE: The FDA provided an update and additional information regarding SynCardia Systems, Inc.'s Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System), as well as to inform you of recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System. The TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. There has continued to be a higher mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console. The mortality rates for patients who did not require pre-implant circulatory rescue interventions were similar for the C2 Driver System compared to the CSS Console.The most recent post-approval study results suggest that there is also a difference in clinical performance between the C2 Driver System and the CSS Console in terms of neurological adverse events.

BACKGROUND: As a condition of approval of the C2 Driver System, FDA required SynCardia to conduct a post-approval study assessing post-market performance. The study relies on data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), and compares outcomes for patients who were initially supported with the C2 Driver System and the CSS Console during the same time period (implanted on June 20, 2012 or after). The most recent results from the ongoing post-approval study regarding mortality and neurological adverse events are in the letter to health care providers.

RECOMMENDATION: The FDA has the following recommendations for health care providers:

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