FDA approves HeartWare's implantable heart pump

Tue Nov 20, 2012 2:18pm EST

Nov 20 (Reuters) - The U.S. Food and Drug Administration said it has approved HeartWare International Inc's heart pump that supports blood flow in people with failing hearts who are awaiting a transplant.

HeartWare's left ventricular assist device is designed to be implanted in the chest near the heart and used inside or outside the hospital.

FDA said the life-saving benefits of the device in the intended population of patients with end-stage heart failure outweighed risks observed during the clinical trial, such as infection and stroke.