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FDA panel to review heart valve for those too sick for surgery

Los Angeles Times, July 20, 2011

When patients need a new heart valve, they can get an artificial one—if they're healthy enough for the conventional method, open-heart surgery. But a new artificial valve, inserted via catheter, doesn't require major surgery at all, and a group of heart experts is meeting Wednesday to weigh in on the device's safety. The artificial Sapien heart valve system, from Edwards Lifesciences, will be reviewed by an advisory panel to the FDA, which doesn't have to follow the panel's advice but usually does. Replacement valves are needed when the aorta, the main artery that carries blood away from the heart, becomes narrowed and prevents blood from flowing normally. The Sapien valve can be threaded through a leg artery to the aorta. In a clinical trial among patients deemed too sick for surgery, those who had the Sapien valve had better survival after a year than those who got other care, including using a balloon catheter to repair the valve.