The U.S. Food and Drug Administration (FDA) released updated information regarding SynCardia System’s Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System, a bridge-to-transplant device for future heart transplant patients with severe bi-ventricular failure. Following an FDA-required post-approval study on its performance, results continued to show "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 rate for patients who did not require pre-implant circulatory rescue interventions were similar for the C2 Driver System compared to the CSS Console." These results indicate there is a difference in clinical performance with regard to neurological adverse effects between the C2 Driver System and the CSS Console. The FDA recommends providers cautiously consider the adverse event results, and report and return any devices related to suspected adverse incidents.

Read the FDA announcement here.

Keywords: Health Personnel, Heart Failure, Heart Transplantation, Heart, Artificial, United States Food and Drug Administration

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