Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its ...

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 ...

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

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

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 ...

Abbott has scored FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR) system, giving fresh hope to ...

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

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

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

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 ...