FDA Advisory Committee Supports Abbott's TriClip™ System for Treating Leaky Tricuspid Heart Valves

Tuesday, February 13, 2024

Abbott has recently disclosed that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) has voted 13 to 1, with no abstentions, in favor of Abbott's TriClip™ transcatheter edge-to-edge repair (TEER) system for treating tricuspid regurgitation (TR). This affirmation was based on data from the TRILUMINATE™ pivotal trial and expert testimonies. The FDA will take this panel's decision into consideration when evaluating TriClip's approval, a pioneering minimally invasive device tailored to address the complex tricuspid valve.

Tricuspid regurgitation can strain the heart and lead to cardiovascular complications, significantly diminishing quality of life. Historically, treatment options for TR have been limited. TR occurs when the tricuspid valve fails to close properly, causing blood to leak backward into the heart. TriClip presents a potential solution for individuals experiencing persistent symptoms or TR despite medical therapy.

Delivered through a leg vein, TriClip's TEER technology clips together a portion of the valve's leaflets to restore proper blood flow without necessitating open-heart surgery. Abbott boasts a comprehensive portfolio of structural heart solutions, including innovative, minimally invasive therapies like MitraClip™ for mitral regurgitation, Amplatzer Piccolo™ Occluder for congenital heart defects in infants, and the Navitor™ transcatheter aortic valve implantation system for aortic stenosis. Abbott remains committed to addressing the unmet needs of patients with structural heart disease and advancing standards of care to enable individuals to live their lives to the fullest.




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