Edwards’ EVOQUE valve system granted CE Mark
CE-marked EVOQUE valve system, a breakthrough for tricuspid valve replacement.
Edwards Lifesciences Corporation has officially announced that their EVOQUE tricuspid valve replacement system has received CE Mark approval for transcatheter treatment of patients with tricuspid regurgitation (TR). This achievement marks a significant milestone, as the EVOQUE system becomes the world’s first transcatheter valve replacement therapy to obtain regulatory clearance for treating TR.
Daveen Chopra, the Corporate Vice President of Transcatheter Mitral and Tricuspid Therapies at Edwards, expressed pride in their commitment to addressing unmet patient needs through innovation. He stated, “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. 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 consists of a nitinol self-expanding frame, an intra-annular sealing skirt, and tissue leaflets made from the same bovine pericardial tissue used in the company’s market-leading heart valves. This valve will be available in three sizes, all delivered through a low-profile transfemoral 28F system.
Prof. Philipp Lurz, the Director of Cardiology at the University of Mainz, Germany, and the European Principal Investigator for the TRISCEND II study, praised the EVOQUE system’s ability to fully replace the tricuspid valve, effectively eliminating tricuspid regurgitation in various anatomical cases. He noted the remarkable improvements in patients’ quality of life, now offering a therapeutic option to many patients who previously had no treatment choices.
One-year results from the single-arm, prospective, global, multi-center TRISCEND study of the EVOQUE system were presented at PCR London Valves 2022. These results demonstrated favorable safety and effectiveness outcomes, as well as significant improvements in quality of life. Notable findings included high survival rates (90.1%), a high freedom from heart failure hospitalization rate (88.4%), significant and sustained reduction of TR to mild or trace levels (97.6%), and substantial enhancements in functional and quality of life outcomes (93% of patients in NYHA Class I or II compared to 26% at baseline, with a 26-point increase in KCCQ score over baseline).
The company plans to present the results from the TRISCEND II pivotal trial, which studies the EVOQUE system, during a late-breaking clinical trial session on October 26 in San Francisco at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
Patients suffering from tricuspid valve disease experience a range of symptoms, from debilitating to life-threatening, with limited effective treatment options. Edwards’ tricuspid portfolio in Europe includes other transcatheter therapies with CE Mark approval, such as the PASCAL Precision transcatheter repair system and the Cardioband annular reduction system. However, the company has not yet received approval for any transcatheter therapies for tricuspid valve treatment in the United States.
About Edwards Lifesciences: Edwards Lifesciences is a global leader in patient-focused innovations for structural heart disease and critical care monitoring. They are dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape.
Please note that this news release contains forward-looking statements, as outlined in the provided disclaimer. These statements are based on management’s estimates and assumptions and are inherently uncertain and difficult to predict. The company does not undertake any obligation to update these statements. Investors are advised not to overly rely on forward-looking statements and to refer to the company’s filings with the Securities and Exchange Commission for more information.