Evoque Tricuspid Valve Replacement System From Edwards Approved in Canada

June 24, 2025—Edwards Lifesciences Corporation announced that the company’s Evoque tricuspid valve replacement system has received Health Canada approval for the treatment of tricuspid regurgitation (TR). According to the company, the Evoque system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT) and for whom tricuspid valve replacement is deemed appropriate by a heart team.

“Patients suffering from severe TR endure debilitating symptoms and poor quality of life and are desperate for effective treatment,” commented Neil Fam, MD, in Edwards’ press release. “The Evoque system is able to fully replace the tricuspid valve, eliminating TR in a wide range of anatomies.”

Dr. Fam, Director of the Structural Heart Program at St. Michael’s Hospital in Toronto, Canada, continued, “The significant improvements in patients’ quality of life are remarkable, with Evoque now offering a therapy to many patients who previously had no treatment options.”

Edwards stated that the Evoque system features a nitinol self-expanding frame, an intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. The Evoque valve will be available in four sizes, all delivered through the same low-profile, transfemoral 28-F system, noted Edwards.

In October 2023, Edwards announced CE Mark for Evoque and FDA approval in February 2024.

The company said that the Evoque system demonstrated superiority compared to medical therapy alone for the 1-year primary endpoint in the TRISCEND II randomized controlled pivotal trial. The data, which were presented at TCT 2024, included significant reduction or elimination of TR and significant improvements in symptoms, function, and quality of life at 1 year, with favorable numerical outcomes in mortality and heart failure hospitalization.