EDWARDS' EVOQUE TRANSCATHETER TRICUSPID VALVE REPLACEMENT SYSTEM EARNS APPROVAL IN CANADA

MISSISSAUGA, ON, June 23, 2025 /CNW/ - Edwards Lifesciences Corporation today announced the company's EVOQUE tricuspid valve replacement system has received Health Canada's approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.

"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, Corporate-Vice President EMEACLA. The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company's proven bovine pericardial tissue. The EVOQUE valve will be available in four sizes, all delivered through the same low-profile transfemoral 28F system.

"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."

Successful results from the randomized controlled pivotal trial, TRISCEND II, were presented at TCT 2024, demonstrating the EVOQUE system's superiority compared to medical therapy alone for the one-year primary endpoint. Key findings in the trial included significant reduction or elimination of tricuspid regurgitation and significant improvements in symptoms, function and quality-of-life at one year, with favorable numerical outcomes in mortality and heart failure hospitalization.

The EVOQUE system received CE Mark approval in October 2023, making it the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR, and earned FDA approval in the US in February 2024.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

SOURCE Edwards Lifesciences