Merit Medical releases 12-Month efficacy results for the single-arm arteriovenous graft cohort of the WRAPSODY arteriovenous efficacy (WAVE) trial

Merit Medical Systems Inc. announced that the 12-month results from the single-arm cohort of the WAVE trial (NCT04540302) were presented at the annual Charing Cross Symposium held in London, on April 23, 2025, during the Vascular Access Masterclass session. Following the scientific podium presentation, results were presented during a Merit-sponsored symposium.

The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy performance goal for covered stents. At 6 months, the TLPP associated with the WRAPSODY CIE was 81.4%, a result 21.4 percentage points higher than the performance goal of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety performance goal (95.4% vs. 89.0%, p=0.016). At 12 months, the TLPP associated with the WRAPSODY CIE was 60.2%. Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2%, respectively.

Twelve-month findings from the randomized arm of the WAVE trial (TLPP: 70.1%; ACPP: 58.1%) were previously presented at the annual Society of Interventional Radiology meeting held in Nashville, TN. Six-month efficacy results (TLPP: 89.8%; ACPP: 72.6%) were published in Kidney International. (see citation).

“Patients with a failing AVG have limited options available to restore functionality of their access,” said Dr. Robert G. Jones, Consultant Interventional Radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, and Co-Principal Investigator of the WAVE trial. “Therefore, it was exciting to present findings to my colleagues, so they are aware of WRAPSODY’s potential to improve care for this vulnerable patient population.”

“We are pleased to have the opportunity to share the positive findings of WRAPSODY with our physician partners, and we look forward to working with them to improve patient outcomes,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.

See- Razavi MK, Balamuthusamy S, Makris AN et aL. Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial. Kidney Int. 2025, 107:740 doi: 10.1016/j.kint.2025.01.006.