FDA Approves Edwards Pascal System for Tricuspid Valve Repair; Irvine-Based Company Also Wins New Mitral Clearance
Edwards Lifesciences, the medical device company headquartered in Irvine, in California's Orange County, announced on October 21 that the U.S. Food and Drug Administration (FDA) has approved its Pascal Precision system for tricuspid valve repair, another key U.S. approval for the company's transcatheter valve repair and replacement portfolio.
According to the company, the Pascal Precision system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation 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. The company said the system's differentiated features help physicians navigate complex and challenging anatomies. '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,' said Santiago Garcia, MD, director of the Structural Heart Program at The Christ Hospital Health Network in Cincinnati, Ohio. One-year results from the CLASP IITR pivotal trial of the Pascal tricuspid system will be presented at TCT 2026.
The FDA also approved the Pascal Ace with Capture Clarity system for use in degenerative mitral transcatheter edge-to-edge repair (M-TEER) procedures. The system includes fluoroscopic indicators that provide confirmation when valve leaflets have been grasped, addressing a challenging step in edge-to-edge repair cases. Dr. Garcia said the indicators provide a novel and easy way of confirming leaflet capture, simplifying placement of the device and increasing confidence in achieving a successful outcome. With the approvals, Edwards now provides a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves available in the United States.
Published by GSM · USA (original Chinese edition)
Photo: 图：心脏瓣膜手术（资料图）。维基共享资源，CC BY 4.0。
