Edwards Lifesciences announced that the SAPIEN 3 Ultra system has received US Food and Drug Administration approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.
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FDA Approves Edwards’ Sapien 3 Ultra TAVR System
Source: Edwards Lifesciences Corporation News Release
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Author(s): Edwards Lifesciences Corporation
