Mortality Concerns with SynCardia Artificial Heart

An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System (C2 Driver System) has shown a higher mortality rate and higher stroke rate for patients initially supported with the device compared to patients initially supported with the previous generation driver, the Circulatory Support System Console. The device functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. It replaces a patient’s native ventricles and valves to completely take over pumping of blood to both the pulmonary and systemic circulation.

An agency notice tells healthcare providers to carefully consider the mortality and stroke results from the post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients.