Edwards Lifesciences Reports PASCAL System For Tricuspid Repair Shows Superiority Compared To Medical Therapy Alone For Six-Month Primary Endpoint Of CLASP II TR Trial

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.

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.