Edwards Valve Comparable To Traditional Surgery, FDA Says

Law360, New York (June 11, 2012, 7:05 PM EDT) -- Patients who received a new, less invasive type of heart valve from Edwards Lifesciences Corp. survived at about the same rate as those undergoing traditional open-heart surgery, but strokes were significantly more common, the U.S. Food and Drug Administration reported Monday.

The announcement comes in advance of a Wednesday hearing where an FDA advisory panel will consider recommending approval of the device in patients for whom traditional surgery is extremely risky, extending it from patients for whom open-heart procedures are not possible.

Edwards won agency backing...
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