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February 21, 2019

Edwards Lifesciences secures CE-Mark for Pascal system

US-based Edwards Lifesciences has secured the European CE-Mark for its Pascal transcatheter valve repair system to treat patients suffering from mitral regurgitation.

US-based Edwards Lifesciences has secured the European CE-Mark for its Pascal transcatheter valve repair system to treat patients suffering from mitral regurgitation.

The device has been developed to reduce mitral regurgitation. It consists of contoured, broad paddles for maximising adjustment of the mitral leaflets.

Pascal is said to enable optimised leaflet capture and positioning. The system also includes a central spacer designed to fill the regurgitant orifice area.

“The system is yet to be approved in the US, where the pivotal CLASP IID trial is being conducted in subjects with symptomatic primary mitral regurgitation.”

Edwards Lifesciences transcatheter mitral and tricuspid therapies corporate vice-president Bernard Zovighian said: “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 system is yet to be approved in the US, where the pivotal CLASP IID trial is being conducted in subjects with symptomatic primary mitral regurgitation.

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CLASP Study investigator Konstantinos Spargias noted: “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.”

Edwards Lifesciences is developing a variety of transcatheter repair or replacement therapies to treat mitral and tricuspid valve diseases.

In May last year, the company received CE-Mark for the Cardioband Tricuspid Valve Reconstruction System that has been developed to treat tricuspid heart valve disease.

The Cardioband system was designed to allow accurate positioning to the specific anatomy of a patient, real-time adjustment and simultaneous confirmation of results.

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