"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, transcatheter mitral and tricuspid therapies. "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 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.
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. It represents the culmination of 20 years of innovation by Edwards to develop a novel, differentiated and advanced platform for patients in need. The company is building upon a long history of knowledge, experience and commitment to advance transformative therapies and develop a robust body of clinical evidence.
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.
Dr. Spargias is a consultant to Edwards Lifesciences.