Edwards’ Pascal TMVR system gains CE mark

The Pascal transcatheter mitral valve repair (TMVR) system has received its CE mark for the treatment of patients with mitral regurgitation, device manufacturer Edwards Lifesciences announced Feb. 19.

According to the company, the system includes “broad paddles to maximize coaptation of the mitral leaflets, and a central spacer that fills the regurgitant orifice area.”

"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,” Bernard J. Zovighian, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, said in the announcement. "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 device is not commercially approved in the United States, but a pivotal U.S. trial called CLASP IID is currently enrolling patients with symptomatic primary regurgitation.

The CE mark approval represents a TMVR milestone for Edwards, which—like other device companies—is attempting to catch up to Abbott in the growing space. Abbott’s MitraClip was the first TMVR device approved by the FDA and made headlines at TCT 2018 with the overwhelmingly positive results of the COAPT trial, although physicians and researchers are still grappling with how to replicate those outcomes in the real world.