Edwards’ Pascal Precision OK’ed for Mitral Valve Repair

Edwards Lifesciences’ Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has earned U.S. Food and Drug Administration (FDA) approval to treat degenerative mitral regurgitation (MR).
 
“Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the U.S.,” Bernard J. Zovighian, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies told the press. “Edwards’ 60-year history of innovation and leadership within structural heart disease positions our team well to bring the PASCAL Precision system to US clinicians, supporting excellent real-world outcomes for patients.”
 
Pascal Precision features independent grasping, atraumatic clasp and closure, and ability to elongate. Its intuitive catheter and handle makes the system maneuverable and stable for precise navigation and implant delivery.
 
“The mitral valve is highly complex and challenging to treat,” said Firas Zahr, M.D., Associate Professor of Medicine, Division of Cardiovascular Medicine, School of Medicine, Oregon Health & Science University, whose patients participated in the CLASP IID clinical trial. “Through my participation in the CLASP IID pivotal trial, I have performed many cases with the PASCAL system. With FDA approval of the PASCAL system, US clinicians now have an additional option for treating patients with severe mitral regurgitation.”
 
Pascal Precision has CE mark approval to treat both mitral and tricuspid regurgitation.