The Edwards Evoque features a nitinol self-expanding frame, intra-annular skirt and tissue leaflets made from bovine pericardial tissue. Edwards intends to offer the valve in four sizes (44mm, 48mm, 52mm and 56mm), all delivered through the same low-profile transfemoral 28F system.
Edwards won CE mark for the Evoque system in October 2023. Evoque then became the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR) in February 2024.
Irvine, California-based Edwards has now shared findings for Evoque at the American College of Cardiology Annual Scientific Session (ACC 2026) in New Orleans. The company said findings demonstrated significant and sustained patient benefits including lower mortality when accounting for patient crossover. It said this extended findings presented at ESC 2025.
New TRISCEND II trial data highlighted confidence in Evoque’s two-year performance. It included significant and sustained near elimination of tricuspid regurgitation (TR) and improvements in health status and quality of life. Investigators saw no added device-related risk and significantly lower all-cause mortality when accounting for patient crossover.
Commentary from Edwards officials and doctors
Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies, said:
“Edwards remains focused on developing innovative solutions that meet the most pressing needs of patients with structural heart disease, and we’re proud of the life-changing benefits demonstrated with the EVOQUE system. In addition to TRISCEND I and II data, the growing body of evidence on Evoque includes data on more than 1,000 patients in the STS/ACC TVT Registry presented at TCT last year, demonstrating consistent near elimination of tricuspid regurgitation, improved quality of life, and a positive real-world safety profile across the broad tricuspid patient population.”
Dr. Vinod Thourani, Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center, Piedmont Heart Institute, said:
“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. Our analyses, including the many highly symptomatic crossover patients, showed significantly improved outcomes for all of the Evoque treated patients.”
