Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, today announced positive 6-month findings from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) during a FIRST@CIRSE presentation.

WRAPSODY is a cell-impermeable endoprosthesis which is intended to extend long-term vessel patency in dialysis patients. Many patients undergoing dialysis rely on a vascular access site created in the arm called an AV fistula. The maintenance of adequate blood flow through this site is crucial for patient survival.

The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to WRAPSODY or percutaneous transluminal angioplasty (PTA). Target lesion primary patency in patients treated with WRAPSODY was 27 percentage points higher than patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001).1 The proportion of patients who experienced an adverse event was similar between cohorts.2