Merit’s Wrapsody Device Evaluated in WAVE Pivotal Trial’s Arteriovenous Graft Cohort

November 25, 2024—Merit Medical Systems, Inc. announced 6-month findings from the single-arm arteriovenous graft (AVG) cohort of the WAVE pivotal trial, which is evaluating the safety and efficacy of the company’s Wrapsody cell-impermeable endoprosthesis. The Wrapsody device is designed to restore and extend vessel access in hemodialysis patients, stated the company.

The data were presented during the Novel Technologies in Hemodialysis Access session at the 51st annual VEITHsymposium held November 19-23, 2024, in New York, New York.

According to the company, the AVG arm of the WAVE trial enrolled 112 patients at 43 international sites. All enrolled patients were treated with the Wrapsody device.

Merit reported that based on survival analysis through 6 months, target lesion and access circuit primary patency for AVG patients in the WAVE trial were 82% and 68.8%, respectively.

The primary efficacy and safety endpoints were a comparison of the actual rates for the Wrapsody device versus performance goal (PG) rates for covered stents. The company reported the following:

• The efficacy endpoint was 81.4% for Wrapsody versus the 60% PG (P < .0001). The primary efficacy outcome was defined as the proportion of patients free from clinically driven target lesion, revascularization, or target lesion thrombosis through 6 months.
• The safety endpoint—the rate of freedom from an adverse event—was 95.4% for Wrapsody versus the 89% PG (P = .0162). The safety outcome included the proportion of patients without any localized or systemic adverse events in the 30 days after treatment that negatively affected the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).

“In light of the historically low patency rates for AVG patients, the positive results from the AVG arm of the WAVE trial are very encouraging for physicians who manage these patients,” commented WAVE Coprincipal Investigator Mahmood K. Razavi, MD, in Merit’s press release. Dr. Razavi is an interventional radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, California.

Leonardo Harduin, MD, an investigator of the WAVE trial, added, “The patency results from the WAVE trial are the highest that I have seen to date and are expected to meaningfully improve patients’ quality of life and vascular access survival. These results will probably have a positive impact on costs related to the care of these patients.” Dr. Harduin is a vascular surgeon at University of Rio de Janeiro State in Rio de Janeiro, Brazil.

In September, the company announced that the 6-month findings from the randomized arteriovenous fistula arm of WAVE were delivered at CIRSE 2024, the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in Lisbon, Portugal.

The company noted that the findings from the WAVE trial expand on results from the first-in-human WRAPSODY FIRST trial, which were published by James Gilbert, et al in CardioVascular and Interventional Radiology (2021;44:1903-1913).

According to Merit, the WAVE data will support the company’s premarket approval application to the FDA for commercial use of the Wrapsody device in the United States.

Currently, the device is being used in the WAVE trial in the United States under an FDA investigational device exemption. The device is commercially available in Brazil and in the European Union, advised the company.