The FDA has recently approved the Edwards SAPIEN XT Transcatheter Heart Valve to be marketed. The Edwards SAPIEN XT Transcatheter Heart Valve (often referred to as the SAPIEN XT) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. For more information, please see: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm405068.htm
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