FDA reviewers say Edwards' heart valve "demonstrated superiority"

07/18/2011 | Reuters

FDA reviewers said Edwards Lifesciences' Sapien transcatheter aortic valve "demonstrated superiority" in a clinical trial involving patients with severe aortic stenosis who are too weak to undergo open-heart surgery. However, the trial also found the device increased the risk of stroke and neurological harm. An FDA advisory panel is set to assess clinical trial data on Edwards' device.

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