The Edwards PASCAL transcatheter valve repair system has received the CE Mark for the treatment of patients with mitral regurgitation, Edwards Lifesciences Corp. announced Tuesday.
“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,” said Bernard J. Zovighian, Edwards' corporate vice president of transcatheter mitral and tricuspid therapies, in the company’s news release. “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 PASCAL system is designed for 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 company said.
“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,” Konstantinos Spargias, transcatheter heart valve director, Hygeia Hospital, Greece, and an investigator in the multi-national prospective CLASP Study, said in the news release.
The PASCAL system is not approved in the United States; the CLASP IID U.S. pivotal trial is currently enrolling patients with symptomatic primary mitral regurgitation.