Edwards Lifesciences (NYSE: EW) today shared new data demonstrating successful outcomes with its mitral and tricuspid therapies.
The company shared new findings for its Evoque and Sapien M3 valves at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. These data add to new long-term findings for Sapien valves also shared at TCT today.
Edwards shared one-year data from the ENCIRCLE single-arm pivotal trial and 30-day data from the EVOQUE STS/ACC TVT registry. ENCIRCLE achieved all primary and secondary endpoints for safety and effectiveness, having data simultaneously published in The Lancet. EVOQUE outperformed results from the company’s previous TRISCEND II pivotal trial for the tricuspid valve.
EVOQUE registry findings
Edwards’ Evoque tricuspid valve offering features a nitinol self-expanding frame, intra-annular skirt and tissue leaflets made from bovine pericardial tissue. Edwards intends to offer the valve in four sizes (44mm, 48mm, 52mm and 56mm), all delivered through the same low-profile transfemoral 28F system.
Irvine, California-based Edwards won CE mark for the Evoque system about two years ago. Evoque became the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR) in February 2024.
Now, the company reports data from 1,034 patients, demonstrating a positive real-world safety profile across a broad tricuspid patient population. That included lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at 30 days compared to TRISCEND II.
Nearly all patients (98%) experienced TR elimination and received discharge home after a median stay of two days post-procedure.
“We now have established a comprehensive portfolio of mitral and tricuspid repair and replacement technologies to ensure patients can receive the right therapy to meet their unique needs,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “The depth and breadth of evidence across our therapies reinforces the compounding value our innovations continue to deliver for patients, physicians and the healthcare system.”
More on the Edwards ENCIRCLE study
ENCIRCLE’s main cohort of 299 patients unsuitable for other treatment options achieved low rates for death and low heart failure hospitalization for patients treated with the SAPIEN M3 transfemoral transcatheter mitral valve replacement (TMVR) system.
Patients who received the Sapien M3 valve therapy also achieved substantial mitral regurgitation (MR) elimination. They also demonstrated significant improvements in symptoms and quality of life.
Sapien M3 treats patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR). Such patients are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. It became the first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR with CE mark in April. Analysts also expect FDA approval for Sapien M3 in 2026.
“Mitral regurgitation is highly prevalent. Many patients do not have good treatment options for mitral intervention, and therefore too many are left untreated. These patients often experience symptoms that are life threatening and significantly impact their quality-of-life,” said Dr. David Daniels, Sutter West Bay Medical Group cardiologist, principal investigator and structural heart section chief of Sutter’s Heart & Vascular Service Line. “These ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a very low 30-day mortality in patients receiving a fully percutaneous mitral valve replacement using the SAPIEN M3 system. This is a significant step forward in the treatment of these patients.”
