Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced results from the AVF cohort of the WRAPSODY (WRAP) Global registry. Clinical data were presented during the New Innovations, Trials, Techniques & Devices session on Saturday, October 31, 2026, at the Controversies in Dialysis Access (CiDA)* conference held in Washington, DC.
Hemodialysis is a life-sustaining therapy for patients diagnosed with advanced kidney disease. For many patients, the creation and long-term maintenance of an AVF is essential for ongoing access to blood vessels (vascular access). However, impairments in and around the fistula due to progressive narrowing (stenosis) and/or blockage (occlusion) are inevitable for some patients. These obstructions can interfere with a patient’s ability to receive hemodialysis, require repeated interventions, and may result in life-threatening consequences.
Merit Medical’s Role in Advancing Vascular Access Solutions
The WRAPSODY™ Cell-Impermeable Endoprosthesis (CIE) was developed to restore functionality in vascular access in patients who experience stenosis/occlusion. The device’s favorable performance has been documented in the clinical trial setting.3–6 Real-world data provide insight into how a medical device performs when used in routine clinical practice, outside the controlled setting of a traditional clinical trial. The WRAP Global registry is an international, multicenter, prospective study designed to evaluate the performance of the WRAPSODY CIE in real-world clinical practice through 24 months following device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries. The 6-month TLPP1 was 92.7%, and the 6-month ACPP2 was 76.7%. These findings align with the patency rates observed in the AVF cohort in the WAVE pivotal trial (6-month TLPP: 89.8%; 6-month ACPP: 72.8%).4
“These are the results physicians have been waiting for,” said Panagiotis M. Kitrou, MD, MSc, PhD, EBIR, FCIRSE, Co-Global Principal Investigator of the WRAP Global registry, Associate Professor of Interventional Radiology at Patras University Hospital in Patras, Greece, and a clinical consultant to Merit Medical. “Real-world insight regarding the patency of WRAPSODY provides an important benchmark for this patient population.”
“The promising patency outcomes from the WRAP Global registry are likely to improve physician confidence in the clinical benefits associated with WRAPSODY and help to further optimize patient care,” said Dheeraj K. Rajan, MD, Co-Global Principal Investigator of the WRAP Global registry, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, who also serves as a clinical advisor to Merit Medical.
“These results reinforce our commitment to building a comprehensive body of clinical evidence for WRAPSODY, which includes both rigorous clinical trials and real-world practice,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “Helping physicians maintain vascular access and reduce the burden associated with repeat interventions is central to what we are working to achieve for patients receiving hemodialysis worldwide.”
The WRAPSODY CIE received premarket approval from the U.S. Food and Drug Administration (FDA) in December 2024 and was approved by Health Canada in April 2025. In January 2025, Merit began commercialization of the device in the United States. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
In addition to the WRAP Global registry, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America registry, which is designed to enroll up to 250 patients in the United States and Canada. For additional information on Merit’s WRAP North America registry, please visit: https://clinicaltrials.gov/study/NCT06807099.
Merit believes that the collective data from the WAVE trial, the WRAP North America registry, and the WRAP Global registry will generate evidence on the largest cohort of patients for a single indication in dialysis access to date.
For more information on the WRAPSODY CIE within the United States, please visit here. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-wrapsody/.