October 19, 2023 — Edwards Lifesciences Corporation announced the company's EVOQUE tricuspid valve replacement system received CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUEsystem is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR.
"Innovating for unmet patient needs is at the center of everything we do at Edwards, which makes us especially proud to have received CE Mark for this first-of-its-kind transcatheter tricuspid valve replacement therapy," said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "With the EVOQUE system's approval, in addition to our current PASCAL tricuspid system, we are now able to provide a broader array of much-needed treatment options for appropriate tricuspid disease patients in Europe."
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.
"The EVOQUE system is able to fully replace the tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of anatomies," said Prof. Philipp Lurz, Director of Cardiology, University of Mainz, Germany and European Principal Investigator for the TRISCEND II study. "The significant improvements in patients' quality-of-life are remarkable, now offering a therapy to many patients who previously had no treatment options."
One-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the EVOQUE system were presented at PCR London Valves 2022 and demonstrated favorable safety and effectiveness outcomes and significant quality-of-life improvements. Key findings included high survival (90.1%) and high freedom from heart failure hospitalization (88.4%); significant and sustained TR reduction to mild or trace TR (97.6%); and significantly improved functional and quality-of-life outcomes (93% of patients in NYHA Class I or II compared to 26% at baseline and a 26-point increase in KCCQ score over baseline).
The company will present results from the TRISCEND II pivotal trial, studying the EVOQUE system, during a late-breaking clinical trial session on Oct. 26 in San Francisco at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
Patients with tricuspid valve disease suffer greatly with symptoms ranging from debilitating to life-threatening with few effective options for relief. Other transcatheter therapies in Edwards' tricuspid portfolio with CE Mark approval include the PASCAL Precision transcatheter repair system and the Cardioband annular reduction system. The company does not yet have any transcatheter therapies approved for treatment of the tricuspid valve in the United States.
For more information: https://www.edwards.com/