FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller

The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System. Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2. The TAH-t system is designed to function as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure, the federal watchdog said. The system is intended to replace a patient’s native ventricles and valves to take over pumping blood for both the pulmonary and systemic circulation. Rates of survival among all patients through three months post-implant were reported at 65.5% for C2 patients, versus 77.5% for CSS Console patients, the FDA said. At six months, survival rates dropped to 60% for C2 patients, versus a higher 74.2% among CSS console patients, according to the report. For patients who did not require pre-implant circulatory rescue interventions, the mortality rate at three months was 69.9% for C2 patients versus 75.6% for CSS patients. At six months, survival rates were 62.6% and 75.6%, respectively. For patients who did receive pre-implant circulatory rescue interve...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news