FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease
Business Wire•21/10/2026•09:00 ET
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Key Highlights
- ➤FDA approves PASCAL Precision for tricuspid repair in symptomatic severe TR patients
- ➤Edwards becomes only U.S. company offering mitral and tricuspid transcatheter repair and replacement
- ➤FDA approves PASCAL Ace with Capture Clarity for degenerative mitral TEER procedures
- ➤Capture Clarity provides fluoroscopic confirmation of valve leaflet grasping during TEER
Expert Statements
Daveen Chopra, Corporate vice president, transcatheter mitral and tricuspid therapies at Edwards Lifesciences
“The PASCAL system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US.”
Daveen Chopra, Corporate vice president, transcatheter mitral and tricuspid therapies at Edwards Lifesciences
“With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal clinical results.”
Santiago Garcia, Director of The Structural Heart Program, The Christ Hospital Health Network
“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 US.”
Santiago Garcia, Director of The Structural Heart Program, The Christ Hospital Health Network
“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.”
FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease
Recent FDA Approval of PASCAL Ace with Capture Clarity Simplifies Mitral TEER Procedures for Clinicians
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