FDA Panel Backs Edwards Heart Valve For Wider Use

Law360, New York (June 14, 2012, 5:46 PM EDT) -- A U.S. Food and Drug Administration advisory panel on Wednesday said a first-of-its-kind, less-invasive heart valve from Edwards Lifesciences Corp. is safe and effective for high-risk patients with severe, symptomatic aortic stenosis, in which the aortic valve does not open fully.

The FDA Circulatory System Devices Panel said the benefits of the Edwards Sapien transcatheter heart valves — which combines stent technology with tissue replacement valves — outweighed the risk for patients at issue, widening approved uses for the device. The agency had already approved the...
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