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Panel of independent experts reviewed data from the TRILUMINATE pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system

Abbott 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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Page Created: April 26, 2024 Last Updated: April 26, 2024