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Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery
The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC) Tendyne ...
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FDA approves Abbott’s TMVR system to treat mitral valve disease
The US Food and Drug Administration (FDA) has granted approval for Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system for individuals with mitral valve disease. This device ...
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FDA approves transcatheter mitral valve replacement system for high surgical risk patients
The self-expanding valve system (Tendyne) is available in multiple sizes adapted to a range of patient anatomies and is fully repositionable and retrievable during implantation, according to a ...
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Abbott Gains FDA Approval for Tendyne™, Strengthening Its Minimally Invasive Heart Portfolio
Abbott Laboratories (NYSE:ABT) has received FDA approval today for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, the first device of its kind approved in the US to treat ...