Edwards Lifesciences Announces New Data on EVOQUE Tricuspid Valve Replacement System

Edwards Lifesciences announced new data on the EVOQUE transcatheter tricuspid valve replacement system at the American College of Cardiology Annual Scientific Session, demonstrating significant and sustained patient benefits including lower mortality when accounting for patient crossover, extending the findings presented at the European Society of Cardiology Congress. The new TRISCEND II trial data presented today during a late-breaking featured research session at ACC.26 demonstrated confidence in two-year performance of TTVR with the EVOQUE system and showed: Significant and sustained near elimination of tricuspid regurgitation; Improvements in health status and quality of life; No added device-related risk; and Significantly lower all-cause mortality when accounting for patient crossover. "There is a significant patient population suffering with debilitating symptoms from tricuspid regurgitation with very limited treatment options. It's not a surprise that the sickest patients enrolled in the medical therapy control group of the randomized TRISCEND II trial opted to receive treatment with the EVOQUE system following the one-year primary endpoint, underscoring both the benefits of and need for TTVR therapy," said Vinod Thourani, MD, FACS, FACC, Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center, Piedmont Heart Institute. "Our analyses, including the many highly symptomatic crossover patients, showed significantly improved outcomes for all of the EVOQUE treated patients." The 18-month data of the TRISCEND II trial were presented at ESC in August 2025, showing achievement of a hard endpoint benefit for the most severe TR patients who received the EVOQUE therapy, and superior quality of life benefits, regardless of baseline TR.