ENCIRCLE mitral trial achieves primary and secondary endpoints

EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial

Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

ENCIRCLE Pivotal Trial Results

One-year outcomes in the ENCIRCLE trial’s main cohort (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. Further, patients receiving the SAPIEN M3 valve therapy achieved substantial mitral regurgitation (MR) elimination (95.7% MR ≤ 0/1+) and significant improvements in symptoms and quality-of-life.

“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 David Daniels, M.D., 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.”

EVOQUE TTVR System STS/ACC TVT Registry Data

With data from 1,034 patients evaluated, findings from the EVOQUE TTVR system STS/ACC TVT Registry demonstrated a positive real-world safety profile across a broad tricuspid patient population. This includes lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at 30 days compared to the TRISCEND II pivotal trial experience. Additionally, almost all patients experienced tricuspid regurgitation (TR) elimination (98% TR ≤ 0/1+) and were discharged to 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 vice president, 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.”

The SAPIEN M3 system was approved in Europe in April 2025 and is not yet approved in the US. The EVOQUE system is approved in both the US and Europe.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, including quality of life and length of stay, value delivered to patients, physicians and the healthcare system and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, EVOQUE, SAPIEN, SAPIEN M3, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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