Edwards’ EVOQUE System Shows Significant, Sustained Benefits After Two Years

New two-year clinical data on Edwards Lifesciences’ EVOQUE transcatheter tricuspid valve replacement (TTVR) system demonstrate significant and durable patient benefits, including reduced mortality after adjusting for patient crossover.

The new TRISCEND II trial data showed:

• Significant and sustained near elimination of tricuspid regurgitation (TR);
• 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, M.D., Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center at 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—presented last summer—showed the EVOQUE system achieved a hard endpoint benefit for the most severe TR patients and superior quality of life advantages, regardless of baseline TR.

“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,” stated Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “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.”

The EVOQUE system is approved in both the United States and Europe.

Edwards Lifesciences is a global structural heart innovation company developing breakthrough technologies backed by evidence, and forming partnerships with clinicians and healthcare stakeholders.