HeartWare Device Approved for Heart Transplant Hopefuls
HeartWare Ventricular Assist System approved for end-stage heart failure patients awaiting transplant
TUESDAY, Nov. 20 (HealthDay News) -- The HeartWare Ventricular Assist System, a left ventricular assist device to help people with end-stage heart failure who are awaiting a transplant, has been approved by the U.S. Food and Drug Administration.
Unlike similar devices that require components to be implanted in the abdomen, the HeartWare device is small enough to be implanted as a single unit near the heart. Approval was granted based on a clinical study of 137 advanced heart failure patients, the FDA said.
The possibility of serious adverse reactions, including stroke and infection, must be weighed against the need for the device, the agency advised.
The device is produced by HeartWare Inc., of Framingham, Mass.