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 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 offers ...

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

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 ...

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

HHS Secretary Robert F. Kennedy Jr. threatened to bar NIH scientists from publishing in leading medical journals, saying the ...