FDA Panel Endorses Abbott's TriClip for Tricuspid Regurgitation Treatment

19th February, 2024

In a decisive vote, experts highlight the benefits of the minimally invasive device, paving the way for potential FDA approval and offering new hope to patients with limited treatment options.

Abbott (NYSE: ABT) has announced a significant milestone in the journey of its TriClip™ transcatheter edge-to-edge repair (TEER) system towards potential approval in the United States. The system, which is designed to treat tricuspid regurgitation (TR), received positive feedback from the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA). With a vote of 13 to 1 in favor, the panel acknowledged the system's benefits over risks based on evidence from the TRILUMINATE™ pivotal trial and expert opinions.

Tricuspid regurgitation is a condition where the heart's tricuspid valve fails to close correctly, leading to backward blood flow and significant health complications. Currently, treatment options are limited for patients not suitable for surgery. The TriClip offers a minimally invasive solution, improving patients' quality of life by allowing blood to flow correctly through the heart without the need for open-heart surgery.

The FDA's advisory panel's support came after a thorough review of clinical data and testimonials regarding the safety, effectiveness, and quality-of-life improvements associated with the TriClip device. The panel's recommendations will play a crucial role in the FDA's final decision on the device's approval, expected in 2024.

Dr. Lars Søndergaard, Abbott's chief medical officer for its structural heart business, highlighted the urgent need for innovative treatments like TriClip for patients with tricuspid regurgitation. The device represents a significant advancement, offering hope for those with few treatment options.

The TriClip system is already making a difference globally, approved in over 50 countries and having treated more than 10,000 people with TR. This investigational device in the U.S. is part of Abbott's broader commitment to providing cutting-edge solutions for structural heart diseases, including mitral regurgitation and aortic stenosis.

As the medical community awaits the FDA's decision, the potential approval of TriClip in the U.S. signifies a promising advancement in the treatment of heart valve diseases, aiming to provide patients with a better quality of life and fewer symptoms related to tricuspid regurgitation.

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