Edwards Pascal Precision System Approved by FDA for Tricuspid Valve Repair

October 21, 2026—Edwards Lifesciences Corporation announced that the FDA has approved its Pascal Precision system for tricuspid valve repair.

According to Edwards, the Pascal Precision system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy who are deemed at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team.

With this approval, Edwards now provides a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves that are available in the United States, noted the press release.

“The differentiated features of the Pascal system provide many benefits in navigating complex and challenging anatomies, and it is exciting to now have this therapy available for our tricuspid patients in the United States,” commented Santiago Garcia, MD, in the Edwards press release. Dr. Garcia is director of The Structural Heart Program, The Christ Hospital Health Network in Cincinnati, Ohio.

The company also announced that the FDA has approved the Pascal Ace with Capture Clarity system for use in degenerative mitral TEER procedures (M-TEER). The system includes fluoroscopic indicators that provide confirmation when valve leaflets have been grasped, addressing a challenging step in TEER cases and simplifying procedural complexity, stated Edwards.

Dr. Garcia commented, “Building on the Pascal system’s intuitive design, the Capture Clarity indicators provide a novel and easy way of confirming leaflet capture, which is critical and can be challenging. This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome.”

Edwards advised that 1-year data from the CLASP IITR pivotal trial studying the Pascal tricuspid system will be presented during late-breaking sessions at TCT 2026 in San Diego, California.