Edwards' Pascal Transcatheter System Receives CE Mark Approval
February 19, 2019—Edwards Lifesciences announced that its Pascal transcatheter valve repair system has received European CE Mark approval for the treatment of patients with mitral regurgitation.
According to the company, 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 not approved in the United States, where the CLASP IID pivotal trial is currently enrolling patients with symptomatic primary mitral regurgitation. In December 2018, the company announced that the first procedure in this trial had been performed in Morristown, New Jersey.
In Edwards' announcement, Konstantinos Spargias, MD, commented, "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." Dr. Spargias, who is Transcatheter Heart Valve Director at Hygeia Hospital in Athens, Greece, serves as an investigator in the multinational prospective CLASP study.