FDA Clears TriClip for Tricuspid Regurgitation

The US Food and Drug Administration (FDA) has approved Abbott’s TriClip Transcatheter Edge-to-Edge Repair (TEER) system to repair severe tricuspid regurgitation (TR), the company has announced. 

The approval follows the recent vote in favor of TriClip by the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee. The vote was 13 to one, with zero abstention, that the benefits of TriClip outweigh the risks.

The committee’s decision and FDA approval was based on results of the randomized controlled TRILUMINATE trial. 

Conducted at 65 centers in the United States, Canada, and North America, the trial enrolled 350 patients with severe TR who were randomly allocated (1:1) to TEER performed with the TriClip delivery system or medical therapy (control).

As previously reported by theheart.org | Medscape Cardiology, patients who underwent repair with the TriClip TEER system experienced a large reduction in valve dysfunction, which was associated with substantial improvement in quality of life that persisted out to 1 year of follow-up. 

TriClip TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.

The results were presented last year at the joint scientific sessions of the American College of Cardiology/World Congress of Cardiology and published inThe New England Journal of Medicine.

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 Paul Sorajja, MD, of Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, and co-principal investigator in the trial, in news release. 

“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,” Sorajja noted. 

TriClip leverages the same clip-based technology as the MitraClip, also from Abbott, which has been used in more than 200,000 people with mitral regurgitation but was specifically designed to treat the tricuspid valve’s complex anatomy, the company said. 

Source link : https://www.medscape.com/viewarticle/fda-clears-triclip-tricuspid-regurgitation-2024a100068o?src=rss

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Publish date : 2024-04-02 17:25:22

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