Edwards Reports on Pascal TMVR System Clinical Studies
May 22, 2019—Edwards Lifesciences announced strategic clinical and regulatory milestones for the company's Pascal transcatheter valve repair system. The Pascal system received CE Mark approval and is available commercially in Europe. It is not approved in the United States.
At EuroPCR, held May 21–24 in Paris, France, Konstantinos Spargias, MD, presented 6-month data from the CLASP study of the Pascal system in patients with clinically significant mitral regurgitation (MR) despite optimal medical therapy.
The company also announced that the FDA has approved CLASP IIF, a prospective, multicenter, randomized, controlled pivotal trial studying the Pascal system.
As presented at EuroPCR, the 6-month CLASP data showed treatment with the Pascal system demonstrated sustained positive outcomes, including 81% of patients with mild (1+) or none/trace MR and 98% with < 2+ MR, with echo core lab adjudication. Additionally, patients experienced clinically and statistically significant improvements in functional status, exercise capability, and quality of life sustained at 6 months.
Edwards stated that these data build on the 30-day CLASP study, which also demonstrated a significant reduction in MR and improvements in quality of life measures. At 30 days, the major adverse events rate was low at 6.5%, and there was no incidence of stroke or myocardial infarction. These results were presented at DGK 2019, the German Society of Cardiology's 85th annual meeting, held April 24–27 in Mannheim, Germany.
The FDA-approved CLASP IIF will evaluate the safety and effectiveness of transcatheter mitral valve repair with Edwards' Pascal system compared with the MitraClip device (Abbott Vascular), for the treatment of moderate-to-severe (3+) or severe (4+) functional MR in symptomatic heart failure patients. The study is expected to begin enrolling in the next few months. The CLASP IID United States pivotal trial is currently enrolling patients with symptomatic primary MR, noted Edwards.