Merit Medical’s WRAPSODY WAVE trial ‘exceeds performance goals’ for AVG patients

Merit Medical (MMSI) Systems announced six-month findings from the single-arm AVG cohort of its WRAPSODY Arteriovenous Access Efficacy pivotal trial. The data were presented at the 51st annual VEITHsymposium during the Novel Technologies in Hemodialysis Access session. An AVG is a synthetic tube that is used for long-term access to blood vessels for patients undergoing hemodialysis. However, over time, the graft may become narrow or blocked, resulting in potentially life-threatening consequences. Merit’s WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore and extend vessel access in hemodialysis patients, which is critical for patient survival. The WAVE trial was designed to evaluate the efficacy and safety of the WRAPSODY device. The AVG arm of the WAVE trial enrolled 112 patients across 43 international sites. All enrolled patients were treated with the WRAPSODY device. Based on survival analysis through six months, target lesion and access circuit primary patency for AVG patients in the WAVE trial were 82% and 68.8%, respectively. Primary efficacy and safety endpoints were assessed by comparing actual rates for the WRAPSODY device to performance goals for covered stents. Efficacy of the WRAPSODY device was 81.4%, which is 21.4 percentage points higher than the PG of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety PG.