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  • FDA ADVISORY COMMITTEE VOTES IN FAVOR OF ABBOTT'S FIRST-OF-ITS-KIND TRICLIP™ SYSTEM TO TREAT PEOPLE WITH A LEAKY TRICUSPID HEART VALVE

    • Panel of independent experts reviewed data from the TRILUMINATE™ pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system
    • An investigational device in the U.S., TriClip is approved in more than 50 countries and has treated more than 10,000 people with tricuspid regurgitation worldwide

    ABBOTT PARK, Ill., Feb. 13, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott's TriClip™ transcatheter edge-to-edge repair (TEER) system outweighed the risks for the treatment of people with tricuspid regurgitation (TR). The panel's decision was based on clinical data from the TRILUMINATE™ pivotal trial, as well as expert testimony. The panel's vote will be considered by the FDA when making a decision regarding the approval of TriClip, a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve.

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