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.

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

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

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

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

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

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

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

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 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 ...