FDA Panel Votes in Favor of Abbott TriClip for Tricuspid Regurgitation

Credit: US Food and Drug Administration

An advisory committee meeting convened by the US Food and Drug Administration concluded with a vote favoring the benefit-risk profile associated with Abbott’s TriClip transcatheter edge-to-edge repair system.

A meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee, the panel voted 13 to 1 with no abstentions that the benefits of the system outweighed the risks for the treatment of tricuspid regurgitation based on data from the TRILUMINATE trial and expert testimony in the February 13, 2024 meeting.

"In the TRILUMINATE pivotal trial, we found that 90% of people who received tricuspid valve repair with the TriClip implant experienced a marked improvement in the severity of their TR with unprecedented procedural safety, and their improvement in quality of life was sustained at one year," said coprincipal investigator of the TRILUMINATE pivotal trialDavid Adams, MD, chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System. "In the TRILUMINATE pivotal trial, we found thatThe TriClip system ushers in a new era of structural therapy for patients suffering from severe tricuspid valve disease."

The lone dissenting vote commended Abbott for the trial and said he considered this a major step forward for patients if the community intends to rely on KCCQ as a trial endpoint.

“I still am troubled by the fact that there was no change in diuretics, there was no consistent story with biomarkers, the imaging data is encouraging. At the end of the day, I ended up being the sole dissenting vote on number 3,” explained Paul J Hauptman, MD, dean of the School of Medicine at University of Nevada, during the meeting. “I would encourage the agency to continue to take a very critical look at the continues access protocol at 1 year because I suspect those data could tip the scales at least in my mind.”

According to Abbott a decision from the FDA for the TriClip is expected 2024. As of February 14, 2024, the system had received approval in more than 50 countries, including Europe and Canada. Billed by Abbott as a first-of-its-kind trial, TRILUMINATE was a randomized, controlled clinical trial designed to assess the safety and efficacy of transcatheter repair with the TriClip system relative to medical therapy in people with symptomatic severe TR who are at intermediate or greater risk for open-heart surgery.^1,2

The trial, which was published in the New England Journal of Medicine in May 2023, enrolled 350 people from 65 centers across the US, Canada, and Europe. The trial’s primary endpoint of interest was a hierarchical composite including death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement in Kansas City Cardiomyopathy Questionnaire score.²

Upon analysis, results of the trial indicated the primary endpoint favored the TriClip group (win ratio, 1.48; 95% Confidence Interval [CI], 1.06-2.13; P=.02). Further analysis suggested there was no difference in incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure between the groups.²

"Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery," said Lars Søndergaard, MD, chief medical officer and divisional vice president of medical affairs of Abbott's structural heart business

References:

1. _{^{Abbott. FDA Advisory Committee votes in favor of Abbott’s first-of-its-kind triclipTM system to treat people with a leaky tricuspid heart valve. Abbott MediaRoom. February 13, 2024. Accessed February 15, 2024. https://abbott.mediaroom.com/2024-02-13-FDA-Advisory-Committee-Votes-in-Favor-of-Abbotts-First-of-Its-Kind-TriClip-TM-System-to-Treat-People-With-a-Leaky-Tricuspid-Heart-Valve.}}
2. _{^{Sorajja P, Whisenant B, Hamid N, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023;388(20):1833-1842. doi:10.1056/NEJMoa2300525}}