Edwards valve repair system receives CE mark approval for tricuspid regurgitation

Edwards Lifesciences’ PASCAL transcatheter valve repair system has gained CE mark approval for treating tricuspid regurgitation (TR).

The PASCAL system was designed for the percutaneous reconstruction of a patient’s tricuspid valve through leaflet repair. In one trial, the solution successfully led to sustained TR reduction in 85% of patients after 30 days.

“Although the prevalence of tricuspid valve disease and the associated mortality are high, there are limited effective treatment options for these very symptomatic patients, who often cannot have surgery due to the prohibitive risk,” Jörg Hausleiter, MD, Medizinische Klinik der Ludwig-Maximilians-Universität München in Munich, Germany, said in a statement. “Transcatheter tricuspid therapy can be challenging due to the fragile leaflets and the large defects during valve closure. In our experience, the PASCAL system's independent grasping ability as well as the  flexible and less traumatic clasp design are important features for our patients.”

“Patients with tricuspid valve disease are in great need of solutions,” added Bernard J. Zovighian, Edwards' corporate vice president of transcatheter mitral and tricuspid therapies. “Edwards is the first company to introduce multiple transfemoral tricuspid repair therapies in Europe, providing physicians with both leaflet repair and annular reduction therapies to help meet their patients' needs.”