FDA Approves TriClip TEER System for Tricuspid Regurgitation

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Less than 2 months after being the subject of an FDA AdComm meeting, Abbott's TriClip TEER System has received approval for tricuspid regurgitation.

FDA Approves TriClip TEER System for Tricuspid Regurgitation

Credit: US Food and Drug Administration

Abbott has announced the US Food and Drug Administration’s approval of the TriClip transcatheter edge-to-edge repair (TEER) system for the treatment of tricuspid regurgitation, or a leaky tricuspid valve.1

Announced on April 2, 2024, the decision is based on data from the TRILUMINATE trial and comes less than 2 months after the FDA’s Circulatory System Devices Panel (CSDP) of the Medical Devices Advisory Committee voted 13 to 1, with 0 abstentions, in favor of the benefit-risk profile of the device.1,2,3

"The US approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said coprincipal investigator of TRILUMINATE Paul Sorajja, MD, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital.1 "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."

A prospective randomized trial, the TRILUMINATE 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. Patients included in the trial were randomized in a 1:1 ratio to receive either TEER or medical therapy. 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 (KCCQ) score.2

Billed by Abbott as a first-of-its-kind trial, results 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

In February 2024, the FDA’s CSDP convened to discuss the risks and benefits of use based on data from the clinical trial program. This meeting concluded in a 13 to 1 vote, with no abstentions, that the benefits of use outweighed the risk in the specified patient population. In that meeting, 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.3

“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.3 “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.”

In their April 02, 2024 announcement, Abbott pointed out the TriClip had been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020, with the device being used to treat more than 10,000 patients with mitral regurgitation worldwide.1

"This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions," said Sandra Lesenfants, senior vice president of Abbott's structural heart business.1 "With the addition of TriClip to our broad structural heart therapy offerings in the US, we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions."

References:

  1. Abbott. Abbott receives FDA approval for TriClipTM, first-of-its-kind device to repair leaky tricuspid heart valve. Abbott MediaRoom. April 2, 2024. Accessed April 2, 2024. https://abbott.mediaroom.com/2024-04-02-Abbott-Receives-FDA-Approval-for-TriClip-TM-,-First-of-Its-Kind-Device-to-Repair-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
  3. Campbell P. FDA panel votes in favor of Abbott triclip for Tricuspid Regurgitation. HCP Live. February 15, 2024. Accessed April 2, 2024. https://www.hcplive.com/view/fda-panel-votes-in-favor-of-abbott-triclip-for-tricuspid-regurgitation.
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