The approval is tightly defined: the system will be for patients ineligible for surgery and with anatomy unfavorable for TEER ...

The system is available for patients whose mitral valves are not working properly due to severe mitral annular calcification.

Abbott (NYSE: ABT) announced today that it received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR ...

The FDA approved Abbott's Tendyne minimally invasive heart replacement for mitral valve disease that could disqualify ...

Abbott Laboratories (NYSE:ABT) has received FDA approval today for its Tendyne™ transcatheter mitral valve replacement (TMVR) ...

The Tendyne system is designated for those who are at high risk for traditional open-heart surgery. It helps with those with ...

US FDA approves Abbott’s Tendyne, first-of-its-kind device to replace the mitral valve without open-heart surgery: Abbott Park, Illinois Thursday, May 29, 2025, 16:00 Hrs [IST] ...

Abbott announced the FDA approved its transcatheter mitral valve replacement system for patients with severe mitral annular ...

The FDA gave the OK for the North Chicago-based medical device maker's Tendyne transcatheter mitral valve replacement.

Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired ...

The US Food and Drug Administration has approved Abbott's Tendyne Transcatheter Mitral Valve Replacement (TMVR) system. It is indicated for patients with mitral valve disease caused by ...