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FDA Approves Abbott's Novel TriClip™ for Repairing Leaky Tricuspid Heart Valve

Abbott has received FDA approval for its innovative TriClip™ transcatheter edge-to-edge repair (TEER) system, designed to treat tricuspid regurgitation (TR), a condition characterized by a leaky tricuspid valve.

TriClip addresses this condition by repairing the tricuspid valve through a vein in the leg, thereby improving blood flow in the heart

TriClip offers a minimally invasive alternative to open-heart surgery, with patients typically requiring only a day in the hospital for recovery.

Tricuspid regurgitation can lead to debilitating symptoms like fatigue and shortness of breath, and if left untreated, it can result in serious complications such as atrial fibrillation and heart failure.

This milestone follows a strong endorsement from the FDA's Circulatory System Devices Panel, which voted 13 to 1 in favor of the TriClip's favorable risk-benefit profile.The FDA's decision was based on data from the TRILUMINATE Pivotal trial, which demonstrated significant improvement in TR severity for 90% of patients at 30 days post-procedure, with sustained benefits observed at one year.

TriClip is addressing the unmet needs of TR patients and expanding Abbott's portfolio of structural heart therapies.

TriClip, leveraging Abbott's expertise in clip-based technology similar to the MitraClip™ device, has already been approved in more than 50 countries and has successfully treated over 10,000 TR patients worldwide since receiving  its CE Mark approval in 2020.

Abbott remains committed to advancing cardiovascular care through innovative solutions like TriClip, aiming to improve patient outcomes and quality of life for individuals with structural heart diseases.


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