Letters to Health Care Providers > SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke - Letter to Health Care Providers

Letters to Health Care Providers > SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke - Letter to Health Care Providers

SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke - Letter to Health Care Providers

Dear Transplant Surgeons and Cardiologists, We are writing to inform you that the FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final 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 (CSS) Console. 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. Continue reading.