Merit Medical Releases 24-Month Efficacy Results from the Randomized Arteriovenous Fistula (AVF) Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial

• The target lesion primary patency (TLPP)1 and access circuit primary patency (ACPP)2 of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) remain superior to percutaneous transluminal angioplasty (PTA) through 24 months
• The clinical improvements associated with the WRAPSODY CIE are projected to improve the interventional landscape for hemodialysis patients who experience venous outflow obstructions

SOUTH JORDAN, Utah, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced positive findings from the randomized AVF arm of the WAVE trial. These findings were presented during the Late-Breaking Clinical Trials session on Tuesday, November 4, 2025, at the Vascular Interventional Advances (VIVA)3 conference held in Las Vegas, Nevada.

Globally, millions of patients with advanced kidney disease require hemodialysis. Administration of hemodialysis requires ongoing vascular access (access to blood vessels) that is often achieved via the surgical creation of an AVF in a central or peripheral vein. However, obstructions, such as stenosis (narrowing) or occlusion (blockage), in the patient veins required for vascular access are common. The WRAPSODY CIE is intended to help physicians restore vascular access in patients on hemodialysis who experience these obstructions.

The WAVE trial was designed to capture the performance of the WRAPSODY CIE. TLPP and ACPP outcomes were used to evaluate the ability of the device to restore functional vascular access in trial patients. Forty-three centers across the United States, South America, and the United Kingdom participated in the trial.

In the randomized arm of the WAVE trial, 245 hemodialysis patients with evidence of venous obstructions in their AVF were treated with either the WRAPSODY CIE (n=122) or PTA (n=123). Twenty-four months following treatment, TLPP was significantly higher among patients treated with the WRAPSODY CIE versus PTA (48.6% vs. 29.8%; p