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

Rhea-AI Summary

Merit Medical (NASDAQ: MMSI) reported 24-month randomized AVF arm results from the WAVE trial showing the WRAPSODY Cell-Impermeable Endoprosthesis (CIE) had superior durability versus PTA.

Key results: target lesion primary patency (TLPP) 48.6% vs. 29.8% (p<0.0001) and access circuit primary patency (ACPP) 31.3% vs. 20.6% (p=0.003) at 24 months in 245 randomized hemodialysis patients across 43 centers. The device has US FDA premarket approval (Dec 19, 2024), Health Canada approval (Apr 30, 2025), CE mark, and availability in Brazil.

Positive

• TLPP 24 months 48.6% vs 29.8% (p<0.0001)
• ACPP 24 months 31.3% vs 20.6% (p=0.003)
• Regulatory approvals FDA PMA (Dec 19, 2024) and Health Canada (Apr 30, 2025)
• Multinational randomized data 245 patients across 43 centers

Negative

• ACPP absolute rate remains modest at 31.3% at 24 months
• TLPP below 50% at 24 months despite superiority (48.6%)

Insights

Clinical vascular device analyst

Randomized WAVE AVF arm shows sustained superiority of the WRAPSODY CIE versus PTA through 24 months, with statistically significant patency benefits.

The WRAPSODY CIE demonstrated higher target lesion primary patency (48.6% vs. 29.8%, p<0.0001) and access circuit primary patency (31.3% vs. 20.6%, p=0.003) at 24 months versus PTA, indicating the device maintains vascular access function longer in the reported trial cohort. The trial enrolled 245 AVF patients across 43 centers and randomized 122 to WRAPSODY CIE and 123 to PTA, which supports internal comparability between arms.

Key dependencies include the durability of patency beyond the measured endpoints, real‑world uptake, and broader registry evidence; the company is running the WRAP North America registry (up to 250 patients) and a WRAP Global registry to collect those outcomes. Monitor the registry enrollment progress and interim registry results over the next 12–36 months and any regulatory or labeling updates tied to these findings; also watch for subgroup data and safety event rates disclosed in future presentations.

• 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<0.0001). Similarly, the ACPP was significantly higher among patients treated with the WRAPSODY CIE versus PTA (31.3% vs. 20.6%; p=0.003). These findings align with the significant clinical benefits demonstrated at 6 months and 12 months.

“Evidence of sustained superiority of the WRAPSODY CIE relative to PTA gives us confidence in the device’s ability to extend functional vascular access,” said David J. Dexter II, MD, FACS, a WAVE trial Investigator and Vascular Surgeon at Sentara Health Research Center in Norfolk, VA, who presented findings from the randomized arm of the trial at the VIVA conference. Dr. Dexter is also the National Principal Investigator of the WRAPSODY North America registry, a study designed to describe clinical outcomes of the WRAPSODY CIE in real-world practice.

“The WRAPSODY CIE was developed to help physicians restore vascular access for patients,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “The significant clinical benefits from the WAVE trial demonstrate how WRAPSODY CIE achieves this goal.”

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.

Collectively, 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.

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 did Merit (MMSI) report from the WAVE trial AVF arm on November 5, 2025?

Merit reported 24-month results showing WRAPSODY CIE TLPP 48.6% vs PTA 29.8% (p<0.0001) and ACPP 31.3% vs 20.6% (p=0.003).

How do the 24-month WRAPSODY CIE results affect MMSI product approvals?

The results support real-world use; WRAPSODY CIE holds FDA PMA (Dec 19, 2024), Health Canada approval (Apr 30, 2025), CE mark, and is available in Brazil.

How many patients and sites were in the randomized AVF arm of the WAVE trial for MMSI?

The randomized AVF arm enrolled 245 hemodialysis patients treated at 43 centers across the United States, South America, and the United Kingdom.

What is the clinical significance of TLPP 48.6% for MMSI investors?

TLPP 48.6% at 24 months indicates significantly fewer target-lesion reinterventions versus PTA, suggesting improved durability of the WRAPSODY CIE.

Does the WAVE trial data include long-term access circuit outcomes for MMSI's WRAPSODY CIE?

Yes; the trial reports 24-month access circuit primary patency (ACPP) with WRAPSODY CIE at 31.3% versus 20.6% for PTA (p=0.003).