Reuters: Regulatory News: UPDATE 1-FDA approves HeartWare pump for heart failure patients

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UPDATE 1-FDA approves HeartWare pump for heart failure patients Nov 20th 2012, 19:46 Tue Nov 20, 2012 2:46pm 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, or LVAD, is designed to be implanted in the chest near the heart and used inside or outside the hospital. Other LVADs on the market require components to be placed in the abdomen. HeartWare's device is also small enough for implantation in smaller adults or patients unable to have an implant in the abdomen. The 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. The device was approved based on data from a study of 137 patients with advanced heart failure who received the HeartWare LVAD that was compared with outcomes from similar patients followed by a medical registry. It was the first time the FDA has approved an LVAD using registry data as a control, the agency said.

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