Merit Medical Announces Health Canada Approval of the WRAPSODY® Cell-Impermeable Endoprosthesis

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has received Health Canada approval for its WRAPSODY Cell-Impermeable Endoprosthesis (CIE), a device designed to treat vascular access stenosis in hemodialysis patients. The device features a unique tri-layer design with superior clinical outcomes demonstrated in the WAVE trial. At 12 months, WRAPSODY showed significantly higher target lesion primary patency (70.1% vs 41.6%) and access circuit primary patency (58.1% vs 34.4%) compared to standard angioplasty. The device, which received FDA approval in December 2024 and CE Mark for European use, will be immediately commercialized throughout Canada from Merit's Toronto distribution center. The innovative design includes an expandable nitinol stent frame, a cell-impermeable middle layer, and a novel inner layer to reduce complications.

Positive

• Superior clinical outcomes with 70.1% target lesion primary patency at 12 months vs. 41.6% for standard treatment
• Immediate commercialization plans in Canada through existing distribution infrastructure
• Innovative tri-layer design addressing previous device limitations
• Already approved in major markets (US, EU, Brazil) showing strong regulatory acceptance

Negative

• None.

Insights

Medical Device Expert

WRAPSODY device approval in Canada brings superior hemodialysis vascular access technology with demonstrated clinical benefits over standard treatment.

The Health Canada approval of Merit Medical's WRAPSODY Cell-Impermeable Endoprosthesis represents a significant development for hemodialysis patients suffering from vascular access stenosis. The device's tri-layer design directly addresses a key failure mechanism in previous technologies - tissue infiltration through PTFE layers.

The most compelling aspect is the clinical performance demonstrated in the WAVE trial. The data shows 70.1% target lesion primary patency at 12 months compared to just 41.6% with standard angioplasty (p<0.0001). Access circuit primary patency showed similar superiority: 58.1% versus 34.4% (p=0.0003). These metrics are crucial clinical endpoints that translate to fewer interventions and improved dialysis efficiency.

The engineering approach behind WRAPSODY is noteworthy. The three-layer construction includes: an expandable nitinol frame with outer ePTFE, a critical cell-impermeable middle layer preventing tissue migration, and an inner "spun" PTFE layer designed to reduce thrombus formation. The inclusion of optimized radial force and compression resistance addresses mechanical challenges in blood vessels during dialysis.

For hemodialysis patients, maintaining functional vascular access is a life-critical necessity. Every failed access circuit means disrupted treatment, additional procedures, and increased morbidity risk. The statistically significant improvements in patency rates suggest this device could meaningfully extend the functional lifespan of vascular access sites compared to current standard treatment.

Financial Analyst

Merit Medical expands WRAPSODY device to Canadian market following recent US launch, building on successful clinical data and leveraging existing distribution infrastructure.

Merit Medical's Canadian approval for WRAPSODY represents the latest commercial expansion for this hemodialysis access device. The company has methodically advanced this product through regulatory channels, with US FDA approval in December 2024, European CE Mark, and now Health Canada clearance.

This approval enables immediate commercialization in Canada through Merit's existing Toronto distribution center, suggesting minimal additional infrastructure investment is required. The company appears to be executing an efficient geographic rollout strategy following the US launch in January 2025.

The WRAPSODY device addresses a crucial clinical need in hemodialysis patient care. The superior clinical outcomes from the WAVE trial provide Merit with strong differentiation in the vascular access market. Specifically, the 70.1% vs 41.6% 12-month primary patency rates represent a compelling value proposition for adoption by Canadian healthcare providers.

Merit's overall strategy appears focused on developing proprietary technologies that improve clinical outcomes while expanding geographic reach. This product supports that approach by addressing a chronic problem (vascular access stenosis) in a growing patient population (hemodialysis patients).

While the press release doesn't specify Canadian market size, this approval continues the company's pattern of geographic expansion and complements Merit's existing product portfolio, which includes approximately 7,300 employees and a combined domestic and international sales force of over 800 individuals supporting global distribution.

• The WRAPSODY CIE is designed to help physicians prolong functional vascular access in hemodialysis patients.
• Approval was supported by superior 12-month target lesion primary patency (70.1%) and access circuit primary patency (58.1%) in the randomized arm of the trial.

SOUTH JORDAN, Utah, May 06, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the Wrapsody Cell-Impermeable Endoprosthesis (CIE) received regulatory approval from Health Canada. With this approval, Merit intends to begin immediate commercialization of the device throughout Canada with devices shipped from Merit’s Toronto distribution center.

Long-term access to blood vessels (vascular access) is critical for patients undergoing hemodialysis. However, stenosis, a narrowing of blood vessels, is a common complication that can have life-threatening consequences if not resolved. Intervention options for patients affected by stenosis have been limited. The WRAPSODY CIE was developed to help physicians effectively treat patients on hemodialysis who experience vascular access stenosis.

In 2010, Merit set out to understand how and why previous devices failed to provide lasting benefits to patients. It became evident that in the previous generation of covered stents/stent grafts a substantial cause of device failure and, ultimately, loss of vascular access, was the presence of tissue within the polytetrafluoroethylene (PTFE) layer.

With this understanding and key clinical insight from Bart Dolmatch, MD, FSIR, Interventional Radiologist at The Palo Alto Medical Foundation in Palo Alto, California, engineers at Merit designed the WRAPSODY CIE. The tri-layer design of the device is unlike any other treatment option currently available. The three layers of the WRAPSODY CIE consist of: (1) an expandable nitinol stent frame fully enveloped by an outer layer of expanded PTFE; (2) a cell-impermeable middle layer that prevents tissue accumulation and migration; and (3) an innermost internal layer that consists of novel “spun” PTFE to reduce fibrin and thrombus formation. Other unique features of the WRAPSODY CIE include optimized radial force, high compression resistance, and softened ends, all of which help the device conform to vessels, reduce stress, and improve dialysis effectiveness. “I believe all of these advancements will translate to better outcomes for patients on hemodialysis,” said Dr. Dolmatch, who was instrumental in the development of the WRAPSODY CIE.

Results from the randomized arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial demonstrated that the WRAPSODY CIE is associated with significantly higher primary patency compared to percutaneous transluminal angioplasty (PTA). At six months, the target lesion primary patency of the WRAPSODY CIE vs. PTA was 89.8% vs. 62.8% (p<0.0001), and the access circuit primary patency was 72.6% vs. 57.9% (p=0.015). At 12 months, the WRAPSODY CIE remained significantly higher than PTA for both target lesion primary patency (70.1% vs. 41.6%, p<0.0001) and access circuit primary patency (58.1% vs. 34.4%, p=0.0003).

“Given the unique vulnerabilities patients on hemodialysis experience, WRAPSODY’s ability to restore vascular access functionality and avoid disruptions in hemodialysis administration is of high value to patients and providers,” said Dheeraj K. Rajan, MD, FRCPC, FSIR, FACR, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, and an investigator in the WAVE trial. “The fact that WRAPSODY is associated with high target lesion and access circuit primary patencies not previously observed in any similar clinical trial to date is compelling and will provide the option to raise the standard for best patient care in Canada.”

“Our WRAPSODY journey is a testament to our determination at Merit to understand, innovate, and deliver the highest quality products to help our physician partners achieve the best outcomes possible for patients,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are committed to remaining at the forefront of hemodialysis care.”

The WRAPSODY CIE received premarket approval (PMA) from the US Food and Drug Administration (FDA) in December 2024. Merit began commercialization of the device in the United States in January 2025. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.

For additional information on Merit Medical’s WAVE trial, 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 clinical trial results for Merit Medical's WRAPSODY CIE (MMSI)?

In the WAVE trial, WRAPSODY showed 70.1% target lesion primary patency and 58.1% access circuit primary patency at 12 months, significantly higher than standard angioplasty (41.6% and 34.4% respectively).

What makes Merit Medical's WRAPSODY CIE device unique for hemodialysis patients?

WRAPSODY features a unique tri-layer design with a nitinol stent frame, cell-impermeable middle layer, and novel inner layer, designed to prevent tissue accumulation and reduce complications in hemodialysis patients.

When did Merit Medical (MMSI) receive FDA approval for WRAPSODY?

Merit Medical received FDA premarket approval (PMA) for WRAPSODY in December 2024 and began US commercialization in January 2025.

Where is Merit Medical's WRAPSODY CIE currently approved for use?

WRAPSODY is approved in the United States (FDA), Canada (Health Canada), European Union (CE Mark), and Brazil.