Merit Medical Releases 24-Month Efficacy Results from the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial

Rhea-AI Summary

Merit Medical (NASDAQ: MMSI) reported 24-month efficacy from the non-randomized AVG cohort of the WAVE trial on Nov 3, 2025. The WRAPSODY CIE achieved a 6-month TLPP of 81.4% versus a 60% performance goal (p<0.0001). At 12 and 24 months TLPP was 60.2% and 41.7%, respectively; access circuit primary patency (ACPP) was 36.2% at 12 months and 25.7% at 24 months. The dataset includes 112 AVG patients across 43 centers; WRAPSODY holds FDA PMA (Dec 19, 2024) and Health Canada approval (Apr 30, 2025).

Positive

• 6-month TLPP 81.4% vs 60% performance goal
• 12-month TLPP 60.2% documented
• Study enrolled 112 AVG patients across 43 centers

Negative

• 24-month TLPP declined to 41.7%
• 24-month ACPP declined to 25.7%

Insights

Interventional Vascular Specialist

Long-term single-arm AVG data show durable device performance with meaningful 6-month superiority and moderate 24-month patency figures.

The WRAPSODY CIE demonstrated a 6-month TLPP of 81.4%, which exceeded the pre-specified performance goal of 60% (p<0.0001), indicating strong short-term lesion-level efficacy. At extended follow-up the device maintained a TLPP of 60.2% at 12 months and 41.7% at 24 months, while circuit-level ACPP was 36.2% at 12 months and 25.7% at 24 months.

Clinically, exceeding the 6-month performance goal is a clear, objective metric that supports regulatory and adoption narratives, and the prior FDA premarket approval and Health Canada clearance reinforce commercial access. Risks include the single-arm, non-randomized design and declining patency over time; both limit direct comparative claims and require cautious interpretation when assessing long-term benefit. Watch ongoing real-world registries (WRAP North America up to 250 patients) and subsequent comparative or randomized data over the next 12–36 months to confirm durability and circuit-level impact.

• At 24 months, the target lesion primary patency (TLPP)¹ was 41.7%
• At 24 months, the access circuit primary patency (ACPP)² was 25.7%

SOUTH JORDAN, Utah, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial. Results of the AVG cohort were presented during the Late-Breaking Clinical Trials session at the annual VIVA Foundation³ Venous Endovascular Interventional Strategies (VEINS) conference held in Las Vegas, NV.

For the millions of patients diagnosed with advanced kidney disease, hemodialysis is a life-saving treatment that replaces the function of the kidneys. The administration of hemodialysis requires ongoing vascular access (access to blood vessels) that is commonly achieved through the surgical creation of an AVG in a central or peripheral vein. However, complications, such as stenosis (narrowing) or occlusion (blockage), in the patient veins required for vascular access are common. The WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) is intended to help physicians restore vascular access in patients on hemodialysis who experience these complications.

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 non-randomized arm of the WAVE trial, 112 patients with a stenosis or occlusion in their AVG were treated with the WRAPSODY CIE. The TLPP at 6 months was compared to historical outcomes (i.e., performance goals) and then documented over 24 months. The TLPP at 6 months exceeded the established performance goal (81.4% vs. 60%; p<0.0001). At 12 and 24 months, the TLPP for patients treated with the WRAPSODY CIE were 60.2% and 41.7%, respectively. At 12 and 24 months, the ACPP for patients treated with the WRAPSODY CIE were 36.2% and 25.7%, respectively.

“The ability of the WRAPSODY CIE to offer patients with a failing AVG the opportunity to extend vascular access is promising; the 24-month efficacy results will be of the utmost importance to physicians,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, CA, and Co-Global Principal Investigator of the WAVE trial. Dr. Razavi presented results from the non-randomized arm of the trial at the VEINS conference.

“The opportunity to provide physicians with the evidence they need to inform patient care is a key priority at Merit,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “The long-term data from the non-randomized arm of the WAVE trial have helped us to appreciate the value that the WRAPSODY CIE can provide patients and physicians.”

On December 19, 2024, the WRAPSODY CIE received premarket approval from the US Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.

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/.

In the United States and Canada, 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. For additional information on Merit’s WRAP North America Registry, please visit: https://clinicaltrials.gov/study/NCT06807099.

Outside of North America, real-world outcomes of the WRAPSODY CIE are being evaluated in the WRAP Global registry.

¹ TLPP 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 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 The VIVA Foundation is a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education, advocacy, research, and philanthropy. To learn more about The VIVA Foundation, please visit www.viva-foundation.org. 

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, 2024 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, 2025, June 30, 2025 and September 30, 2025, 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 client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.

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

FAQ

What 24-month results did Merit report for WRAPSODY in AVG patients (MMSI) on Nov 3, 2025?

Merit reported 24-month TLPP 41.7% and 24-month ACPP 25.7% in the non-randomized AVG cohort.

How did WRAPSODY perform versus the 6-month TLPP goal in the WAVE trial (MMSI)?

WRAPSODY achieved a 6-month TLPP of 81.4% versus a 60% performance goal (p<0.0001).

How many patients and centers were in the WAVE AVG cohort reported by Merit (MMSI)?

The non-randomized AVG cohort included 112 patients treated across 43 centers.

What regulatory clearances does WRAPSODY CIE have as of Nov 3, 2025 (MMSI)?

WRAPSODY received FDA premarket approval (Dec 19, 2024), Health Canada approval (Apr 30, 2025), and CE mark.

What do TLPP and ACPP measure in the WAVE trial for WRAPSODY (MMSI)?

TLPP measures freedom from target lesion reintervention or thrombosis; ACPP measures access-circuit patency until reintervention or abandonment.

Are real-world studies ongoing for WRAPSODY after the WAVE results (MMSI)?

Yes; Merit is enrolling the WRAP North America Registry (up to 250 patients) and a WRAP Global registry.