FDA Clears TriClip for Tricuspid Regurgitation

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.

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

The results were presented last year at the joint scientific sessions of the American College of Cardiology/World Congress of Cardiology andUS 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...

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