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FDA Approves Expanded Use of SAPIEN 3 Ultra RESILIA Valve System

FDA has approved the expanded use of the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System. Initially designed for aortic valve replacement, this advanced valve system is now indicated for the replacement of failing surgical biological mitral valves in patients who are at intermediate or higher risk for open-heart surgery. This represents a significant…

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