HeartWare Device Approved for Heart Transplant Hopefuls
TUESDAY Nov. 20, 2012 -- The HeartWare Ventricular Assist System, a pumping 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.
Known as a left ventricular assist device (LVAD), it helps the weakened heart's left ventricle pump oxygen-rich blood to the body, the agency said Tuesday in a news release.
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.
The U.S. National Library of Medicine has more about heart failure.
Posted: November 2012