CE Mark for PASCAL transcatheter valve repair system for reduction of mitral regurgitation- . Edwards Lifesciences
Edwards Lifesciences Corporation announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation.
The PASCAL system is designed for effective reduction of mitral regurgitation while respecting the native anatomy. It features contoured, broad paddles to maximize coaptation of the mitral leaflets, and a central spacer that fills the regurgitant orifice area. The delivery system allows for independent leaflet capture and the ability to optimize leaflet position. "The PASCAL system is uniquely designed for optimized valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their patients," said Konstantinos Spargias, THV Director, Hygeia Hospital, Greece, and an investigator in the multi-national prospective CLASP Study.
Comment: The CLASP IID pivotal trial is currently enrolling patients with symptomatic primary mitral regurgitation and is designed to enroll 130 patients and follow them through 3 years.
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