CLASP II TR Trial Demonstrates Superior Clinical, Quality-of-Life Benefits With Edwards PASCAL System
Key Highlights
- ➤PASCAL achieved superiority versus medical therapy alone at CLASP II TR’s six-month primary endpoint
- ➤80% achieved ≤ moderate tricuspid regurgitation at one year versus 30% for controls
- ➤PASCAL patients improved quality-of-life scores by 18 points at one year
- ➤Low adverse-event rates at 30 days demonstrated patient safety
- ➤FDA approved PASCAL for tricuspid valve repair in October 2026
Expert Statements
Charles J. Davidson, Executive Vice Chair for Clinical Affairs, Department of Medicine, Northwestern University, Feinberg School of Medicine
“These CLASP II TR results build upon an already established body of strong clinical evidence supporting the PASCAL system for tricuspid patients.”
Charles J. Davidson, 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.”
Daveen Chopra, Corporate vice president, transcatheter mitral and tricuspid therapies, Edwards
“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.”
Daveen Chopra, Corporate vice president, transcatheter mitral and tricuspid therapies, Edwards
“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.”
CLASP II TR Trial Demonstrates Superior Clinical, Quality-of-Life Benefits With Edwards PASCAL System
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.
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