CLASP II TR Trial Demonstrates Superior Clinical, Quality-of-Life Benefits With Edwards PASCAL System

SAN DIEGO--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced that the PASCAL system for tricuspid repair demonstrated superiority compared to medical therapy alone for the six-month primary endpoint of the CLASP II TR trial. The evidence further showed significant reduction of tricuspid regurgitation (TR) and substantially improved health status, both sustained through one year. The data were presented during late-breaking clinical trial sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

Among the CLASP II TR patients treated with the PASCAL system, 80% achieved ≤ moderate TR at 1 year vs. 30% in the control group and showed a clinically significant 18-point improvement in patient quality-of-life measures as reported in the Kansas City Cardiomyopathy Questionnaire. Patient safety was demonstrated by low adverse event rates at 30 days.

“These CLASP II TR results build upon an already established body of strong clinical evidence supporting the PASCAL system for tricuspid patients,” said Charles J. Davidson, MD, Executive Vice Chair for Clinical Affairs, Department of Medicine, Northwestern University, Feinberg School of Medicine. “The PASCAL system’s ability to elongate to avoid chordal entanglement, atraumatic leaflet grasping, and precise navigation are especially well-suited to navigate complex and challenging tricuspid valve anatomies, making it a differentiated treatment option for these patients.”

Inclusive of CLASP II TR, five randomized studies have shown the positive impact of tricuspid intervention. Among these, the randomized TRIC-I-HF study, published in The New England Journal of Medicine¹, demonstrated a hard-endpoint benefit. This growing body of evidence has established a proven foundation for the life-changing benefits of treating patients with tricuspid valve disease. The PASCAL system received FDA approval for tricuspid valve repair in October 2026 and CE Mark in 2020, with thousands of tricuspid patients treated worldwide.

“Edwards is delivering on our long-standing commitment to develop a portfolio of transcatheter mitral and tricuspid therapies, backed by a body of world-class evidence,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We believe our portfolio enables a personalized treatment path for the millions suffering with mitral and tricuspid valve disease worldwide by providing advanced repair and replacement options for these patients in need of effective solutions.”

¹ Hausleiter J, et al. Transcatheter Tricuspid-Valve Intervention in Heart Failure. N Engl J Med. 2026; 395:1056-1065. doi:10.1056/NEJMoa2606934.

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, statements regarding expected product benefits, positive impact of tricuspid intervention, establishment of a proven foundation for life-changing benefits of treating patients with tricuspid valve disease, 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, CLASP, CLASP II, and PASCAL are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.