Potential Lawsuit: FDA Warns of Continued High Death Rates with Syncardia Heart Transplant Devices

Washington, DC: The US Food and Drug Administration has issued an update to healthcare providers, informing them of the latest findings from the SynCardia TAH-t post-approval study. The results support earlier findings which show a continued higher three-month 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. [Original Article]