After reviewing final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System), the U.S. Food and Drug Administration (FDA) reported higher rates of mortality and stroke for patients initially supported with the C2 Driver System when compared to patients initially supported with the previous generation driver, the Circulatory Support System Console.

SynCardia's TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure by replacing a patient's native ventricles and valves to completely take over pumping of blood to both the pulmonary and systemic circulation. The C2 Driver System is one of the available external pneumatic drivers used to activate the implanted device.

The FDA recommends that health care providers carefully consider these results when making treatment decisions and discuss the risks and benefits of the C2 Driver System with patients. Providers should return all devices associated with adverse events to the manufacturer for evaluation to help better understand the issue. Health care professionals and patients are encouraged to report adverse events to the FDA's online MedWatch Safety Information and Adverse Event Reporting Program.

Clinical Topics: Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Advocacy, Centers for Medicare and Medicaid Services, U.S., Outpatients, Medicare, Fee Schedules, Medicaid, Physicians, Documentation, Medical Records, Heart Failure, Primary Health Care

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