FDA approves novel TEER device for treatment of severe tricuspid regurgitation
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Key takeaways:
- The FDA approved a novel transcatheter edge-to-edge repair device for the treatment of severe tricuspid regurgitation.
- The approval is based on the positive results of the TRILUMINATE pivotal trial.
Abbott announced the FDA approved its novel transcatheter edge-to-edge repair system designed for the treatment of tricuspid regurgitation.
In February, the FDA’s Circulatory System Devices Panel voted to recommend the transcatheter edge-to-edge repair (TEER) device (TriClip) for patients with severe tricuspid regurgitation following review of the results of the pivotal TRILUMINATE trial.
In patients with severe tricuspid regurgitation, transcatheter repair was safe, reduced severity of tricuspid regurgitation and conferred improved quality of life at 1 year, according to the trial results presented at the 2023 American College of Cardiology Scientific Session.
As Healio previously reported, the advisory panel members voted 13-1 that the benefits of the TEER device outweigh any risks in adults with severe tricuspid regurgitation; 12-2 that the delivery system is effective for patients with severe tricuspid regurgitation who meet the criteria of the proposed label indication; and 13-0 that the device is safe.
The TEER device is designed using the same clip-based technology as the company’s device to treat mitral regurgitation (MitraClip) and is delivered through a vein in the leg, according to a company press release.
The average hospital stay for patients who underwent TEER using the present device was 1 day, according to the release.
"The U.S. 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," 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, said in the 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 [tricuspid regurgitation] who are generally older and sicker."
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