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FDA reviews safety of innovative heart valve

06/11/2012 majac Your Health Matters

FILE-This Tuesday, Sept. 21, 2010, file photo, shows a model of a minimally invasive heart valve by Edwards Lifesciences Corp. in Washington. The Food and Drug Administration said Monday, June 11, 2012, that the heart valve compared favorably to surgery after one year, with patients living about the same amount of time. However, reviewers said patients who got the Sapien valve had a higher rate of stroke in the month after the procedure. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber. (AP Photo/Jacquelyn Martin, File)Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use.

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