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

Both six-month patency measures were higher than the corresponding results in the WAVE pivotal trial.

Rhea-AI Summary

Merit Medical Systems (MMSI) reported six-month WRAPSODY results from the arteriovenous fistula cohort of its global registry, covering 237 patients. The cohort spanned 31 sites in nine countries. Target lesion primary patency—freedom from specified repeat treatment or clotting at the treated site—was 92.7%, versus 89.8% in the WAVE pivotal trial. Access circuit primary patency, measuring maintenance of vascular access without reintervention or abandonment, was 76.7%, versus 72.8% in WAVE.

The prospective registry evaluates routine clinical use through 24 months after device placement. Results were presented on October 31, 2026, at the Controversies in Dialysis Access conference. A separate North American registry is designed to enroll up to 250 patients.

Positive

• Minor pointSix-month target lesion primary patency reached 92.7%, versus 89.8% in the WAVE AVF cohort.
• Minor pointSix-month access circuit primary patency reached 76.7%, versus 72.8% in the WAVE AVF cohort.
• Minor pointWRAPSODY received FDA premarket approval in December 2024; U.S. commercialization began in January 2025.
• Minor pointWRAPSODY received Health Canada approval in April 2025 and previously obtained a European Union CE Mark.
• Minor point. Forward-looking: it has not happened yet and may not happen.WRAP North America is evaluating real-world outcomes, with enrollment designed for up to 250 patients.

Negative

• None.

Key Figures

AVF cohort enrollment: 237 patients 6-month TLPP: 92.7% 6-month ACPP: 76.7% +2 more

AVF cohort enrollment

237 patients

WRAP Global registry

6-month TLPP

92.7%

WRAP Global registry AVF cohort

6-month ACPP

76.7%

WRAP Global registry AVF cohort

6-month TLPP

89.8%

WAVE pivotal trial AVF cohort

6-month ACPP

72.8%

WAVE pivotal trial AVF cohort

Key Terms

arteriovenous fistula, stenosis, occlusion, premarket approval

4 terms

arteriovenous fistula medical

"arteriovenous fistula (AVF) cohort"

An arteriovenous fistula is an abnormal or surgically created shortcut between an artery and a vein that lets high-pressure blood flow directly into a low-pressure vessel. Think of it like punching a hole that connects a fast water main to a slower drain: it changes pressure and flow patterns and can affect nearby tissue. Investors should care because fistulas influence demand for surgical procedures, dialysis access devices, monitoring technologies and follow-up care, and therefore can affect healthcare costs, reimbursement and related medical-device and services markets.

stenosis medical

"progressive narrowing (stenosis) and/or blockage (occlusion)"

Stenosis is the abnormal narrowing of a body passage or opening—commonly arteries, heart valves, or the spinal canal—that restricts flow of blood, nerves, or other fluids. For investors, stenosis matters because it drives demand for surgeries, implants, drugs and diagnostic tests, affects patient outcomes and treatment costs, and can influence clinical trial results and the sales prospects of medical products tied to treating or diagnosing the condition.

occlusion medical

"progressive narrowing (stenosis) and/or blockage (occlusion)"

Occlusion is the blocking or closing of a blood vessel or other bodily passage that reduces or stops normal flow—like a kink in a garden hose that prevents water from getting through. For investors, occlusion matters because it is the biological problem many drugs, medical devices and diagnostic tests are designed to treat or detect; its frequency, severity and how well treatments work affect clinical success, regulatory approval, market demand and potential revenue.

premarket approval regulatory

"received premarket approval from the U.S. Food and Drug Administration"

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• The 6-month target lesion primary patency (TLPP)¹ and access circuit primary patency (ACPP)² for patients in the arteriovenous fistula (AVF) cohort were 92.7% and 76.7%, respectively
• The real-world patency results observed in the WRAP Global Registry are higher than the patency results from the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, validating the already favorable performance of the device
  
  

SOUTH JORDAN, Utah, Nov. 05, 2026 (GLOBE NEWSWIRE) -- 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.

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: https://www.merit.com/product/wrapsody-cie/. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-wrapsody/.

Cautionary statement regarding forward-looking statements

Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling approximately 900 individuals. Merit employs approximately 7,500 people worldwide.

*ABOUT CiDA

Controversies in Dialysis Access (CiDA) is a leading multidisciplinary educational forum dedicated to advancing the care of patients requiring dialysis access. Established in 2003, CiDA brings together vascular surgeons, interventional radiologists, nephrologists, and other healthcare professionals to examine current challenges, emerging technologies, clinical research, and evolving approaches to dialysis access management. Through expert presentations, interactive debates, case discussions, and hands-on education, CiDA promotes collaboration and the exchange of knowledge to improve patient care.

For more information, visit www.dialysiscontroversies.org.

TRADEMARKS

Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.

CONTACTS
PR/Media Inquiries
Sarah Comstock
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com

INVESTOR INQUIRIES
Mike Piccinino, CFA, IRC
Westwicke - ICR
+1-443-213-0509 | mike.piccinino@westwicke.com

1. TLPP (primary effectiveness endpoint) was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis.
2. ACPP (a secondary effectiveness endpoint) was defined as the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access.
3. Gilbert et al. 2021. “First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients.” Cardiovasc Interv Radiol 44, no. 12 (Dec): 1903–13. doi: 10.1007/s00270-021-02953-8.
4. Razavi et al. 2025. “Six-Month Safety and Efficacy Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” Kidney Int 107, no. 4 (Apr): 740–50. doi: 10.1016/j.kint.2025.01.006.
5. Razavi et al. 2026. “One-Year Clinical Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108593. Online ahead of print. doi: 10.1016/j.jvir.2026.108593.
6. Razavi et al. 2026. “Safety and Effectiveness of the Wrapsody Cell-Impermeable Endoprosthesis to Treat Dysfunctional Arteriovenous Grafts: Results from the Nonrandomized Arm of the WAVE Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108594. Online ahead of print. doi: 10.1016/j.jvir.2026.108594.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Merit Medical's six-month WRAPSODY global registry results?

The arteriovenous fistula cohort recorded 92.7% target lesion primary patency and 76.7% access circuit primary patency at six months. Corresponding results in the WAVE pivotal trial were 89.8% and 72.8%. The registry cohort enrolled 237 patients across 31 sites in nine countries.

What do the WRAPSODY registry's patency endpoints measure?

Target lesion primary patency, the primary effectiveness endpoint, measures the proportion of patients who did not require intervention for clinically driven repeat treatment or clotting at the treated site. Access circuit primary patency, a secondary effectiveness endpoint, measures the proportion without loss of vascular access anywhere in the circuit from initial treatment to reintervention or abandonment.