Edwards Lifesciences has received Health Canada approval for its Evoque tricuspid valve replacement system to treat tricuspid regurgitation (TR).

Evoque is indicated to improve health status in patients with symptomatic, severe TR despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.

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

The system earned CE mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to gain regulatory approval to treat TR. It received U.S. Food and Drug Administration (FDA) approval in the U.S. in February 2024.

AT TCT 2024, Edwards presented successful results from the TRISCEND II pivotal trial. Data showed Evoque’s superiority compared to medical therapy alone for the one-year primary endpoint. Key findings included reduction or elimination of TR and significant improvements in symptoms, function, and quality of life at one year. There were also favorable numerical outcomes in mortality and heart failure hospitalization.

“As the only global MedTech company solely focused on structural heart disease, Edwards has a long history of pioneering breakthrough implantable devices that address unmet needs of patients suffering this life-threatening and life-limiting condition,” said Annette Brüls, Edwards’ corporate VP of EMEACLA.

“Patients suffering from severe tricuspid regurgitation endure debilitating symptoms and poor quality of life and are desperate for effective treatment. The EVOQUE system is able to fully replace the tricuspid valve, eliminating tricuspid regurgitation in a wide range of anatomies,” said Dr. Neil Fam, Interventional Cardiologist and Director of the Structural Heart Program at St Michael’s Hospital, Toronto. “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.”