Merit Medical Releases 12-Month Efficacy Results for the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY® Arteriovenous Efficacy (WAVE) Trial

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has announced 12-month efficacy results for its WRAPSODY Cell-Impermeable Endoprosthesis (CIE) device from the single-arm arteriovenous graft (AVG) cohort of the WAVE trial. The study included 112 patients with AVG treated with WRAPSODY CIE.

Key findings include:

• 6-month target lesion primary patency (TLPP) of 81.4%, exceeding the performance goal of 60% by 21.4 percentage points
• 12-month TLPP of 60.2%
• Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2% respectively
• 95.4% of patients were free from adverse events, surpassing the safety goal of 89.0%

The WRAPSODY CIE is currently available in Brazil, the European Union, and is approved for commercial distribution in the United States.

Positive

• Device exceeded performance goals with 81.4% TLPP at 6 months vs 60% target
• Safety performance surpassed goals with 95.4% of patients free from adverse events
• Product already approved and commercially available in US, EU, and Brazil

Negative

• Significant decline in patency rates from 6 to 12 months (TLPP: 81.4% to 60.2%)
• Access circuit primary patency showed substantial drop from 69.2% to 36.2% at 12 months

Insights

Medical Device Analyst

Merit's WRAPSODY stent shows strong patency rates in dialysis vascular access, exceeding performance goals and securing key market approvals.

The 12-month results from Merit Medical's WAVE trial provide compelling evidence for their WRAPSODY Cell-Impermeable Endoprosthesis in treating failing arteriovenous grafts (AVGs), which are critical for hemodialysis patients. The device achieved 60.2% target lesion primary patency (TLPP) at 12 months, following an impressive 81.4% at 6 months—significantly outperforming the established 60% performance goal by 21.4 percentage points.

These results address a substantial clinical need. For dialysis patients, maintaining functional vascular access is literally life-sustaining, with failing access requiring frequent interventions. The safety profile further strengthens the clinical case, with 95.4% of patients remaining free from adverse events, exceeding the safety performance goal of 89.0%.

While the data shows the typical decline in patency rates over time (TLPP dropping from 81.4% to 60.2% and access circuit primary patency from 69.2% to 36.2% at 12 months), these results align with the challenging nature of maintaining long-term vascular access.

The commercial implications are significant—WRAPSODY has already secured regulatory approvals in the US, European Union, and Brazil. The previous randomized arm results showed slightly better 12-month outcomes (TLPP: 70.1%; ACPP: 58.1%), while the publication of 6-month data in Kidney International provides scientific validation.

The presentation at the prestigious Charing Cross Symposium, with endorsement from Principal Investigator Dr. Robert Jones highlighting "WRAPSODY's potential to improve care for this vulnerable patient population," should drive clinical awareness and potential adoption among interventional radiologists and nephrologists who manage these challenging cases.

In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months.

SOUTH JORDAN, Utah, May 05, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced that the 12-month results from the single-arm cohort of the WAVE trial were presented at the annual Charing Cross Symposium held in London, England, on April 23, 2025, during the Vascular Access Masterclass session. Following the scientific podium presentation, results were presented during a Merit-sponsored symposium.

The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy performance goal for covered stents. At 6 months, the TLPP associated with the WRAPSODY CIE was 81.4%, a result 21.4 percentage points higher than the performance goal of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety performance goal (95.4% vs. 89.0%, p=0.016). At 12 months, the TLPP associated with the WRAPSODY CIE was 60.2%. Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2%, respectively.

“Patients with a failing AVG have limited options available to restore functionality of their access,” said Robert G. Jones, MBChB, FRCR, Consultant Interventional Radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, and Co-Principal Investigator of the WAVE trial. “Therefore, it was exciting to present findings to my colleagues, so they are aware of WRAPSODY’s potential to improve care for this vulnerable patient population.”

“We are pleased to have the opportunity to share the positive findings of WRAPSODY with our physician partners, and we look forward to working with them to improve patient outcomes,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.

Twelve-month findings from the randomized arm of the WAVE trial (TLPP: 70.1%; ACPP: 58.1%) were previously presented at the annual Society of Interventional Radiology meeting held in Nashville, TN. Six-month efficacy results (TLPP: 89.8%; ACPP: 72.6%) were published in Kidney International.

The Merit WRAPSODY CIE is available in Brazil and in the European Union and is approved for commercial distribution in the United States. For additional information on Merit Medical’s WAVE study, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302. 

ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable 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 7,300 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 are the 12-month efficacy results for Merit Medical's WRAPSODY CIE device (MMSI)?

The WRAPSODY CIE device showed a target lesion primary patency (TLPP) of 60.2% at 12 months, with access circuit primary patency (ACPP) of 36.2%.

How did Merit Medical's WRAPSODY device perform in the 6-month WAVE trial results?

At 6 months, the device achieved 81.4% target lesion primary patency, exceeding the performance goal of 60% by 21.4 percentage points, with 95.4% of patients free from adverse events.

Where is Merit Medical's WRAPSODY CIE device currently available?

The WRAPSODY CIE device is currently available in Brazil, the European Union, and is approved for commercial distribution in the United States.

How many patients were included in Merit Medical's WRAPSODY WAVE trial AVG cohort?

The single-arm cohort of the WAVE trial included 112 patients with arteriovenous graft (AVG) who were treated with the WRAPSODY CIE device.

What was the safety performance of Merit Medical's WRAPSODY device in the WAVE trial?

The device demonstrated strong safety performance with 95.4% of patients free from adverse events, surpassing the safety performance goal of 89.0% (p=0.016).