EDWARDS EVOQUE TRANSCATHETER TRICUSPID VALVE REPLACEMENT SYSTEM RECEIVES CE MARK

Edwards Lifesciences also presented TRISCEND II six-month data for first 150 patients successfully demonstrating safety, efficacy of the EVOQUE system with improvements in quality-of-life and functional outcomes for patients

NEWBURY, Nov. 22^nd, 2023 – Edwards Lifesciences announced the company’s EVOQUE tricuspid valve replacement system received CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUE system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR. Patients with tricuspid valve disease suffer greatly with symptoms ranging from debilitating to life-threatening with few effective options for relief.

"The EVOQUE system has the capability to effectively replace the tricuspid valve, resulting in significant improvements in patients’ quality-of-life,” said Prof Phil Maccarthy, Interventional Consultant Cardiologist, King’s College Hospital. “This innovative approach virtually eliminates tricuspid regurgitation across a wide spectrum of anatomies, providing renewed hope to patients who previously had no treatment options.”

During a late-breaking clinical trial session at the 35^th Transcatheter Cardiovascular Therapeutics (TCT), the company presented successful results from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the groundbreaking EVOQUE tricuspid valve replacement system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization.

The outcomes for the first 150 patients of the TRISCEND II trial achieved the primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone. EVOQUE also achieved substantially superior quality of life outcomes at six months.

Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR). The EVOQUE valve was successfully implanted in 95.8 percent of patients and the trial met all primary endpoints with:

• Major adverse event rate at 27.4 percent at 30 days;
• Significant TR grade reduction with 98.8 percent of patients achieving ≤ moderate TR and 93.8 percent achieving ≤ mild TR at six months; and
• Substantially superior quality-of-life and functional outcomes at six months for the composite endpoint including KCCQ, NYHA and 6MWD for the EVOQUE system plus OMT over OMT alone.

“Patients suffering from severe tricuspid regurgitation endure debilitating symptoms and poor quality of life and are desperate for effective treatment, as evidenced by the rapid enrollment in this trial,” said Nick Walker, Senior Country Director at Edwards Lifesciences UK and Ireland. “This data builds upon the promising foundation of results previously published from the single-arm TRISCEND study and add to our growing body of contemporary clinical evidence that enables more patients in need to receive treatment.”

The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the same bovine pericardial tissue as the company’s market-leading heart valves. The EVOQUE valve will be available in three sizes, all delivered through a low-profile transfemoral 28F system.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, X and YouTube.