CE mark for Pascal mitral valve repair system

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Edwards Lifesciences now has the CE mark for its Pascal transcatheter mitral valve repair system. According to a press release, the system is designed for reduction of mitral regurgitation while respecting the native anatomy. It features contoured, broad paddles to maximise coaptation of the mitral leaflets, and a central spacer that fills the regurgitant orifice area. The delivery system, the press release notes, allows for independent leaflet capture and the ability to optimize leaflet position.

Konstantinos Spargias (Hygeia Hospital, Greece), who is an investigator in the multi-national prospective CLASP study of the Pascal system, says: “The Pascal system is uniquely designed for optimised valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their patients.”

Bernard J Zovighian, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies, notes: “Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality. The introduction of the Pascal system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation.”

The press release reports that the Pascal system is one of multiple transcatheter repair or replacement therapies designed to address mitral and tricuspid valve diseases that are under development by Edwards Lifesciences.

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