Merit Medical Presents Real-World Data from the AVF Cohort of the WRAP Global Registry

WRAPSODY device shows strong 6-month patency rates in real-world dialysis access study.

What the company is saying

Merit Medical Systems, Inc. is highlighting the real-world performance of its WRAPSODY Cell-Impermeable Endoprosthesis (CIE) for hemodialysis patients, emphasizing that the device achieved a 6-month target lesion primary patency (TLPP) of 92.7% and a 6-month access circuit primary patency (ACPP) of 76.7% in the AVF cohort of the WRAP Global registry. The company frames these results as consistent with those from the WAVE pivotal trial, reinforcing confidence in WRAPSODY’s effectiveness. The announcement features remarks from Panagiotis M. Kitrou, MD, and Dheeraj K. Rajan, MD, both serving as Co-Global Principal Investigators, who describe the results as an important benchmark and likely to boost physician confidence. CEO Martha G. Aronson positions these findings as part of a broader strategy to build a comprehensive clinical evidence base for WRAPSODY. The company also notes regulatory milestones: FDA premarket approval in December 2024, Health Canada approval in April 2025, and U.S. commercialization beginning January 2025, with prior CE Mark approval for the EU and availability in Brazil. The tone is confident and data-driven, focusing on clinical validation and international regulatory progress.

What the data suggests

The WRAPSODY CIE achieved a 6-month TLPP of 92.7% and a 6-month ACPP of 76.7% among 237 patients across 31 sites in nine countries in the WRAP Global registry. These rates closely match the WAVE pivotal trial’s AVF cohort outcomes (6-month TLPP: 89.8%, 6-month ACPP: 72.8%), supporting the device’s consistency and reliability in both controlled and real-world settings. The registry is designed for 24 months of follow-up, but only 6-month data are disclosed here. Regulatory approvals have been secured in the U.S. (FDA, December 2024), Canada (April 2025), the European Union (CE Mark), and Brazil, with U.S. commercialization underway since January 2025. The WRAP North America registry, targeting up to 250 patients in the U.S. and Canada, is ongoing but no results are reported yet. Merit Medical employs approximately 7,500 people worldwide. No revenue, profit, or cost data are disclosed, so financial impact cannot be assessed from this update. The clinical evidence is robust, but the absence of financial metrics limits insight into commercial traction.

Analysis

The announcement is primarily a factual update on realised clinical results from the WRAPSODY Global registry, with specific 6-month patency rates and enrollment figures disclosed. The majority of claims are realised and supported by numerical data, including regulatory approvals and commercial launch dates. Forward-looking statements are limited to expectations about future physician confidence and the potential for the combined registries to represent the largest cohort, but these are clearly separated from the core clinical results. There is no evidence of exaggerated language or narrative inflation; the tone is positive but proportionate to the disclosed progress. No large capital outlay or long-dated, uncertain returns are referenced. The absence of financial metrics (revenue, profit, margins) means the signal cannot be strong_positive, but the clinical evidence is robust and well-supported.

Risk flags

• ●The absence of disclosed financial metrics such as revenue, sales volume, or market penetration for WRAPSODY means investors cannot assess the commercial impact or adoption rate of the device, despite strong clinical results.
• ●The current data covers only the first 6 months post-device placement; longer-term durability and complication rates will not be known until the full 24-month registry data is available, introducing uncertainty about sustained performance.
• ●While regulatory approvals and initial commercialization have been achieved, no information is provided on competitive landscape, reimbursement status, or physician uptake, which could materially affect future sales and market share.

Bottom line

Merit Medical’s WRAPSODY device has demonstrated high 6-month patency rates in a large, real-world international registry, closely matching pivotal trial outcomes and validating its clinical performance for dialysis access. Regulatory approvals in the U.S., Canada, EU, and Brazil, along with ongoing commercialization, signal that the product is already on the market and accessible to patients. However, the announcement does not provide any financial data, sales figures, or adoption rates, so the commercial impact remains unclear. The next key milestones will be the release of longer-term (24-month) registry data and initial results from the WRAP North America registry. For investors, the most important takeaway is that clinical risk appears low, but commercial traction and financial returns are not yet demonstrated in the disclosed data.

Announcement summary

(NASDAQ:MMSI) Merit Medical Systems, Inc. announced results from the AVF cohort of the WRAPSODY (WRAP) Global registry, with clinical data presented on October 31, 2026, at the Controversies in Dialysis Access (CiDA) conference in Washington, DC. The WRAPSODY™ Cell-Impermeable Endoprosthesis (CIE) is designed to restore vascular access functionality in hemodialysis patients experiencing stenosis or occlusion. The WRAP Global registry is an international, multicenter, prospective study evaluating the WRAPSODY CIE in real-world clinical practice for up to 24 months post-device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries. The 6-month target lesion primary patency (TLPP) was 92.7%, and the 6-month access circuit primary patency (ACPP) was 76.7%. These results are consistent with the AVF cohort in the WAVE pivotal trial, which reported a 6-month TLPP of 89.8% and a 6-month ACPP of 72.8%. Panagiotis M. Kitrou, MD, MSc, PhD, EBIR, FCIRSE, Co-Global Principal Investigator of the WRAP Global registry and Associate Professor of Interventional Radiology at Patras University Hospital in Patras, Greece, stated that these results provide an important benchmark for this patient population. Dheeraj K. Rajan, MD, Co-Global Principal Investigator and Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, commented that the promising patency outcomes are likely to improve physician confidence in WRAPSODY and optimize patient care. Martha G. Aronson, President and Chief Executive Officer of Merit Medical, emphasized the company's commitment to building a comprehensive body of clinical evidence for WRAPSODY. 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. Merit began commercialization of the device in the United States in January 2025. The device previously received the CE Mark for commercial use in the European Union and is available in Brazil. The WRAP North America registry is also evaluating real-world clinical outcomes of the WRAPSODY CIE and is designed to enroll up to 250 patients in the United States and Canada. Merit believes that the combined data from the WAVE trial, WRAP North America registry, and WRAP Global registry will generate evidence on the largest cohort of patients for a single indication in dialysis access to date. Merit Medical employs approximately 7,500 people worldwide.

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