FDA reviews safety of innovative heart valve |
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 |
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. read more..
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