Evoque transcatheter tricuspid replacement system receives CE Mark.- Edwards Life Sciences

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 October 26 in San Francisco at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.