The EVOQUE Tricuspid Valve System is the first device to receive U.S. Food and Drug Administration (FDA) approval for transcatheter therapy of tricuspid regurgitation (TR), manufacturer Edwards Lifesciences announced Friday. The EVOQUE device has an indication to treat patients who have symptomatic, severe TR refractory to optimal medical therapy (OMT) and who are deemed appropriate for the therapy by a heart team. “Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies, in a company news release. “We are grateful for the strong collaboration with clinicians all over the world who contributed to the EVOQUE system now being available through FDA’s Breakthrough Pathway to provide a treatment option to the many patients in the US suffering with tricuspid valve disease.” The approval comes after early results from the TRISCEND II randomized controlled trial were presented in October at Transcatheter Cardiovascular Therapeutics (TCT) 2023. Results from the first 150 subjects met the trial’s primary safety endpoint, major adverse events (MAE) at 30 days. The upper bound of the 97.5% confidence interval was 36.9%, below the expected MAE rate of 43.8% based on Medicare fee-for-service claims of isolated tricuspid replacement surgeries performed between 2011 and 2018. At 6 months, patients in the EVOQUE arm had a significantly greater reduction in TR grade than patients in the OMT-only group. A win-ratio analysis of the hierarchical quality-of-life metrics showed a win ratio of 4.6, with a lower bound of the 97.5% confidence interval of 2.6, in favor of the EVOQUE group (EVOQUE win rate 60% vs. OMT win rate 13%). The device is made of a nitinol self-expanding frame, intra-annular sealing skirt and bovine pericardial tissue leaflets. The valve will be available in three sizes, the company’s news release says. Image Credit: Edwards Lifesciences