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

ABT wins FDA approval for its Tendyne TMVR system, offering a minimally invasive mitral valve replacement for high-risk patients with severe MAC.

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

Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system was approved by the FDA and indicated for those with ...

Abbott has announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne transcatheter mitral valve replacement (TMVR) system to treat people 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] ...

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 ...

Abbott Laboratories ABT has recently received Food and Drug Administration (“FDA”) approval for its Tendyne transcatheter mitral valve replacement (“TMVR”) system. The Tendyne system ...