Abbott Laboratories has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Tendyne™ transcatheter mitral valve replacement (TMVR) system. This pioneering device offers a minimally invasive alternative for patients suffering from mitral valve disease due to severe mitral annular calcification $(MAC)$, particularly those who are not candidates for open-heart surgery. The Tendyne system, distinguished by its innovative design and availability in multiple sizes, can be delivered through a small chest incision and is fully repositionable during implantation. This approval further expands Abbott's portfolio of minimally invasive structural heart therapies in the U.S., reinforcing its leadership in mitral valve solutions.
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