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 interventions, survival rates were even lower for C2 patients, at 58.4% versus 79.2% for CSS patients at three months. At six months, survival rates were 55.8% for C2 patients and 72.9% for CSS patients.
Rates of stroke were higher for C2 patients as well, with a rate of 26.5% at three months post implant and 27% at six months, versus a lower 7.9% at three months and six months for CSS patients.
“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,” the FDA wrote in its letter.
The agency said it will continue to work with Syncardia to “ensure that the product labeling addresses the post-approval study findings,” and will keep the public informed of any new or additional info.
In October 2016, SynCardia released an update on issues with its Temporary Total Artificial Heart’s Companion 2 driver system and released information on neurological adverse event issues with its pneumatic Freedom driver system.