Reuters: Regulatory News: FDA approves HeartWare's implantable heart pump

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FDA approves HeartWare's implantable heart pump Nov 20th 2012, 19:18 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.

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