Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation.
The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area, the Irvine, Calif.-based company said.
The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position, Edwards 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,” transcatheter mitral and tricuspid therapies corp VP Bernard Zovighian said in a press release.
Edwards said that is engaged in a U.S. pivotal trial of the device, the CLASP IID study, which it hopes will support eventual FDA clearance of the system.
“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,” CLASP sutdy investigator Konstantinos Spargias of Greece’s Hygeia Hospital said in a prepared statement.
Last week, Edwards said that it inked a deal to acquire CAS Medical System (NSDQ:CASM) and its non-invasive brain tissue oxygenation monitoring tech for approximately $100 million.
