August 20, 2018
FDA issues Safety Alert for Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems
Editor's Note
The Food & Drug Administration (FDA) on August 17 issued a Safety Alert for SynCardia Systems’ (Tucson, Arizona) Temporary Total Artificial Heart Companion 2 Driver System.
Final results from a post-approval study indicate higher mortality and stroke rates for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System Console.
The C2 Driver System was approved by the FDA in 2012.
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