Edwards Lifesciences describes transcatheter mitral programme for PASCAL system to treat mitral regurgitation

Today at the EuroPCR annual course in Paris, new 6-month data from the CLASP study of the PASCAL system from Edwards Life were presented by Konstantinos Spargias, M.D., from the Hygeia Hospital in Athens, Greece. Patients enrolled in the CLASP study had clinically significant mitral regurgitation (MR) despite optimal medical therapy. The results from treatment with the PASCAL system demonstrated sustained positive outcomes at six months, including 81 percent of patients with mild (1+) or none/trace MR and 98 percent with <2+ MR, with echo core lab adjudication.

Patients experienced clinically and statistically significant improvements in functional status, exercise capability and quality of life sustained at six months. These data build on the 30-day CLASP study results presented last month at the German Society of Cardiology (DGK), which also demonstrated significant reduction in MR and improvements in quality of life measures.

At 30 days, the major adverse events rate was low at 6.5 percent, and there was no incidence of stroke or myocardial infarction (MI).

In addition, the FDA has approved CLASP IIF, a prospective, multicenter, randomized, controlled pivotal trial studying the PASCAL system. The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients. The study is expected to begin enrolling in the next few months. Edwards already has underway the CLASP IID U.S. pivotal trial, which is currently enrolling patients with symptomatic primary mitral regurgitation.

Comment:Edwards Lifesciences announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation.