Merit Medical Announces FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has received FDA premarket approval for its WRAPSODY Cell-Impermeable Endoprosthesis, enabling US commercialization in 2025. The device is designed to extend long-term vessel patency in dialysis patients who rely on arteriovenous (AV) fistulas or grafts.

The WRAPSODY device features a unique three-layer design with a nitinol stent frame, addressing common complications like stenosis and thrombosis. Clinical results from the WRAPSODY WAVE trial showed impressive target lesion primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months.

Merit will host an informational conference call on January 28, 2025, to discuss the commercial opportunity.

Positive

• FDA approval received for WRAPSODY device, enabling US market entry in 2025
• Strong clinical trial results with 89.8% and 82.0% target lesion primary patency rates for AV fistula and graft patients
• Addresses a large market with 687,000 annual dialysis access procedures in the US
• Innovative three-layer design potentially offering competitive advantages

Negative

• None.

Insights

Medical Device Analyst

The FDA approval of Merit Medical's WRAPSODY Cell-Impermeable Endoprosthesis represents a significant technological breakthrough in dialysis care. The device's unique three-layer design with cell-impermeable technology addresses a critical failure point in current stent solutions - tissue accumulation within the PTFE layer. The 89.8% and 82.0% target lesion primary patency rates at six months for AV fistula and AV graft patients respectively are remarkably high for this application.

With 687,000 dialysis access maintenance procedures performed annually in the US, including 100,000 stent placements, WRAPSODY is positioned to capture a substantial market share. The device's superior design and clinical outcomes could make it the new standard of care, potentially driving significant revenue growth for Merit Medical in the $1+ billion vascular access device market.

Market Research Analyst

This approval positions Merit Medical to significantly expand its market presence in the dialysis care segment. The addressable market is substantial - with over 500,000 Americans receiving dialysis and each patient requiring multiple maintenance procedures annually. A conservative estimate suggests WRAPSODY could capture 20-30% of the stent placement procedures within 2-3 years of launch, representing a potential annual revenue opportunity of $150-200 million.

The timing of the 2025 commercialization allows Merit adequate preparation for a full-scale launch. The company's established distribution network in the vascular access market should facilitate rapid adoption among healthcare providers. The strong clinical data and unique technological advantages will likely support premium pricing strategies.

• Unique cell-impermeable¹ design extends life-saving treatment for dialysis patients
• Merit to host a WRAPSODY informational call on January 28, 2025

SOUTH JORDAN, Utah, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that the WRAPSODY^® Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and Drug Administration (FDA). With this approval, Merit can begin commercialization of the device in the USA in 2025.

WRAPSODY is designed to extend long-term vessel patency in dialysis patients². Many patients undergoing dialysis rely on a vascular access site created in the arm called an arteriovenous (AV) fistula (surgically joining an artery and vein) or an AV graft (a soft tube placed in the arm). The maintenance of adequate blood flow through these sites is crucial for patient survival. Over time, life-threatening access site complications can arise, including stenosis (narrowing of the vasculature) and thrombosis (blood clot formation).

Each year in the United States, 687,000 procedures are performed to maintain dialysis access; nearly 100,000 of these procedures involve placement of a stent (a flexible woven metal tube, often with a covering) to preserve blood flow.³

While covered stents have improved long-term patency, stenosis is still common in patients receiving hemodialysis treatment. A key contributor to stenosis is the accumulation of tissue within the polytetrafluoroethylene (PTFE) layer of these devices. To address this challenge, in 2010, Merit engineers collaborated with Bart Dolmatch, MD, FSIR, Interventional Radiologist at Palo Alto Medical Foundation in Palo Alto, California, to develop the WRAPSODY Cell-Impermeable Endoprosthesis.

“Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment,” said Dr. Dolmatch, who is credited as co-inventor of WRAPSODY device. “I believe the advancements that the WRAPSODY device offers will translate to better outcomes for hemodialysis patients.”

The WRAPSODY Cell-Impermeable Endoprosthesis consists of a proprietary covering that features a nitinol stent frame enveloped by an expandable PTFE outer layer, an inner-luminal layer of novel “spun” PTFE designed to reduce platelet and fibrin formation,¹ and a middle cell-impermeable layer designed to prevent transgraft tissue migration or accumulation.¹ The nitinol frame provides enhanced radial force, compression resistance, and softened ends to help the device conform to vessels, withstand physiological compression, and reduce stress on vessel walls.⁴

Results from the WRAPSODY WAVE pivotal trial demonstrated that AV fistula and AV graft patients receiving treatment with the WRAPSODY device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82.0%, respectively, at six months. The primary patency of the entire access circuit at six months in patients with an AV fistula and AV graft were 72.6% and 68.8%, respectively.

“Historically, interventions for patients who experience a stenosis in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple re-interventions,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, Calif., and Co-Principal Investigator of the WAVE trial. “Results from the WAVE trial have demonstrated that the WRAPSODY device is associated with high patency rates and is likely to become the new standard of care.”

“Over the past decade, Merit has worked to ensure that the WRAPSODY device helps physicians achieve the best possible outcomes for patients,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are proud to design and deliver such an innovative solution that has demonstrated the highest efficacy to date.”

Learn more about the Wrapsody device.

WRAPSODY Informational Call:

Merit will host an informational conference call on Tuesday, January 28, 2025, at 4:30 p.m. Eastern (3:30 p.m. Central, 2:30 p.m. Mountain, and 1:30 p.m. Pacific) to discuss the forecasted opportunity the U.S. commercialization of WRAPSODY represents for the Company in the coming years.

To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details.

A live webcast can be accessed using this link. A link to both register for the conference call and view the webcast will be made available at merit.com.

A replay and summary materials from the presentation will also be available on the investor relations page of Merit’s website.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Statements contained in this release which are not purely historical, including, without limitation, statements regarding results, outcomes and applications of clinical trials, studies and investigations involving Merit’s products, forecasted results and consequences of regulatory approvals related to Merit’s products, safety, efficacy and patient and physician adoption of Merit’s products, Merit’s ability to maintain required regulatory approvals for its products, forecasted plans, revenues and other operating and financial measures, or future growth and profit expectations or forecasted economic conditions, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”) and other filings with the US Securities and Exchange Commission (the “SEC”). Such risks and uncertainties include inherent risks and uncertainties related to the safety, efficacy and patient and physician adoption of Merit’s products, the ability to fully enroll and the final results and outcomes of clinical trials and studies involving Merit’s products, the ability to obtain and maintain reimbursement codes for Merit’s products, Merit’s ability to procure and maintain required regulatory approvals for its products; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the European Union Medical Device Regulation, and risks that such products may not be developed successfully or approved for commercial use; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the US Food & Drug Administration or comparable regulatory authorities in other jurisdictions; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; changes in healthcare policies or markets related to healthcare reform initiatives; and other factors referenced in the 2023 Annual Report and other materials filed with the SEC.

All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. All forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements.

ABOUT MERIT MEDICAL 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 700 individuals. Merit employs approximately 7,200 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

¹ Based upon evaluation of the device in an ovine external iliac artery model. Data on file.
² The WRAPSODY Cell-Impermeable Endoprosthesis is a flexible, self-expanding endoprosthesis indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the dialysis access outflow circuit, including stenosis or occlusion: In the peripheral veins of individuals with an arteriovenous (AV) fistula and At the venous anastomosis of a synthetic AV graft. Refer to instructions for use for complete safety information.
³ Clarivate, Decision Resources Group. “Dialysis Access Treatment Devices. Market Insights.” 2021 Annual Report.
⁴ Based on bench testing. Data on file.

FAQ

What are the clinical trial results for Merit Medical's WRAPSODY device (MMSI)?

The WRAPSODY WAVE trial showed target lesion primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months. Access circuit primary patency rates were 72.6% and 68.8% respectively.

When will Merit Medical (MMSI) begin WRAPSODY commercialization in the US?

Merit Medical will begin commercialization of the WRAPSODY device in the United States in 2025 following FDA premarket approval.

What is the market size for Merit Medical's WRAPSODY device (MMSI)?

In the United States, 687,000 procedures are performed annually to maintain dialysis access, with nearly 100,000 involving stent placement.

What makes Merit Medical's WRAPSODY device (MMSI) unique?

WRAPSODY features a proprietary three-layer design with a nitinol stent frame, PTFE outer layer, spun PTFE inner layer to reduce platelet formation, and a cell-impermeable middle layer to prevent tissue migration.

When is Merit Medical's (MMSI) WRAPSODY informational call scheduled?

Merit Medical will host an informational conference call on January 28, 2025, at 4:30 p.m. Eastern Time to discuss WRAPSODY's commercial opportunity.