The Food and Drug Administration Aug. 17 issued a safety alert after reviewing the final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System. SynCardia’s TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The study results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver – the Circulatory Support System Console – FDA said. “We recommend that you carefully consider these mortality and stroke results from the TAH-t post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients,” FDA said in a letter to providers. FDA also encourages providers to report any adverse events or suspected adverse events experienced with the SynCardia TAH-t and Driver Systems.

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