Edwards Pascal Demonstrates Superiority Over Medical Therapy at 6 Months in CLASP II TR Trial

November 2, 2026—Edwards Lifesciences Corporation announced that its Pascal system for tricuspid repair demonstrated superiority compared with medical therapy alone for the 6-month primary endpoint of CLASP II TR. According to the company’s press release, reductions in tricuspid regurgitation (TR) and improvements in health status were sustained through 1 year.

The findings were presented during a late-breaking clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The results come after the Pascal system’s FDA approval for tricuspid valve repair in October 2026. The system received CE Mark for tricuspid repair in 2020, and thousands of patients with tricuspid valve disease have since been treated worldwide, according to Edwards.

At 1 year, 80% of patients treated with Pascal achieved ≤ moderate TR, compared with 30% in the control group. Pascal-treated patients also showed an 18-point improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire, which the company described as clinically significant. Edwards reported 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,” stated Charles J. Davidson, MD, Executive Vice Chair for Clinical Affairs, Department of Medicine, Northwestern University, Feinberg School of Medicine, in the company’s announcement.

“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.”

Edwards stated that five randomized studies, including CLASP II TR, have shown benefits of tricuspid intervention. The company cited TRIC-I-HF, published by Hausleiter et al in The New England Journal of Medicine (NEJM; 2026;395:1363-1373), as demonstrating a hard-endpoint benefit.