Abbott Laboratories Receives FDA Approval for Tendyne™, First Transcatheter Mitral Valve Replacement Device for Patients Ineligible for Open-Heart Surgery

Reuters
05-27
Abbott Laboratories Receives FDA Approval for Tendyne™, First Transcatheter Mitral Valve Replacement Device for Patients Ineligible for Open-Heart Surgery

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Abbott Laboratories published the original content used to generate this news brief via PR Newswire (Ref. ID: CG94943) on May 27, 2025, and is solely responsible for the information contained therein.

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