Tuesday, April 16, 2024

FDA Approves Abbott’s TriClip for Tricuspid Regurgitation: A New Horizon in Heart Valve Repair

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Abbott has announced that its TriClip™ transcatheter edge-to-edge repair (TEER) system, a groundbreaking device tailored for treating tricuspid regurgitation (TR) or a leaky tricuspid valve, has received approval from the U.S. Food and Drug Administration (FDA). This innovative, minimally invasive treatment offers a significant advancement for patients who require tricuspid valve repair but are deemed unfit for surgery due to the risks involved. With over 1.6 million individuals in the U.S. suffering from tricuspid regurgitation, this condition poses a severe detriment to their quality of life.

Findings from the TRILUMINATE™ Pivotal trial have showcased that patients undergoing the TriClip procedure witnessed substantial improvements in symptom severity and overall quality of life, with the benefits persisting for up to a year. The FDA’s approval is based on the compelling evidence presented by the Circulatory System Devices Panel of the Medical Devices Advisory Committee, which strongly supported the device’s efficacy and safety with a 13 to 1 vote, recognizing that TriClip’s advantages significantly outweigh its risks.

TriClip’s FDA Approval Ushers in New Era for Tricuspid Regurgitation Treatment

Paul Sorajja, M.D., from the Minneapolis Heart Institute Foundation, highlighted the importance of TriClip’s U.S. approval, noting its potential to transform the lives of those affected by tricuspid regurgitation by providing a safe and effective alternative to high-risk surgeries. TriClip, delivered via a vein in the leg, employs TEER technology to clip the valve’s leaflets together, effectively repairing the valve and improving blood flow, usually requiring only a day’s hospital stay for recovery.

The FDA’s clearance was influenced by data from the TRILUMINATE Pivotal trial, the first randomized, controlled clinical study of its kind, which demonstrated a significant reduction in tricuspid regurgitation severity among patients treated with TriClip compared to those receiving medical therapy alone. This landmark study further confirmed TriClip’s favorable safety profile and its ability to significantly enhance patients’ quality of life.

Tricuspid Regurgitation

A Global Leap Forward in Tricuspid Regurgitation Care and Cardiovascular Innovation

Sandra Lesenfants, senior vice president of Abbott’s structural heart business, expressed that TriClip addresses a critical need for patients with TR, offering them a viable option to improve their daily lives and prevent further complications. TriClip, which utilizes technology similar to Abbott’s MitraClip™ for mitral regurgitation, is now part of Abbott’s extensive portfolio of structural heart solutions, marking another step forward in the company’s commitment to innovative cardiovascular care.

Now approved in over 50 countries, including Europe and Canada, TriClip has already benefited more than 10,000 individuals worldwide. Abbott continues to lead in the field of structural heart disease solutions, focusing on fulfilling the unmet needs of patients and enhancing the quality of cardiovascular care globally.

 

Resource: Abbott, April 02, 2024

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