First Patients Enrolled in the Merit WRAPSODY AV Access Efficacy Pivotal Study
Merit Medical Systems (NASDAQ: MMSI) has initiated its pivotal WAVE Study to assess the safety and effectiveness of the WRAPSODY Endovascular Stent Graft for treating dialysis outflow circuit stenosis or occlusion. The first two patients have been enrolled at RAC Surgery Center, Raleigh, NC. This multicenter study aims to recruit 357 patients across the U.S., Europe, Canada, and New Zealand, with a two-year follow-up. The WRAPSODY system, already holding a CE Mark, is designed to improve vascular access in over two million global hemodialysis patients, addressing common complications in dialysis procedures.
- Initiation of the WAVE Study represents a significant step in evaluating the WRAPSODY Stent Graft's effectiveness.
- Previous successful completion of the WRAPSODY FIRST feasibility study supports confidence in the current study.
- The WRAPSODY system has received the CE Mark, indicating regulatory approval in European markets.
- None.
U.S. pivotal study to determine safety and effectiveness of the WRAPSODY Endovascular Stent Graft System in the treatment of dialysis outflow circuit stenosis or occlusion
SOUTH JORDAN, Utah, March 11, 2021 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today the enrollment of the first patients in its Wrapsody ArterioVenous (AV) Access Efficacy Pivotal Study (the “WAVE Study”) of the WRAPSODY™ Endovascular Stent Graft, an investigational device being studied for the treatment of stenosis or occlusion within dialysis outflow circuits. Jeffrey Hoggard, MD at RAC Surgery Center LLC, Raleigh, NC successfully enrolled the first two subjects with venous outflow peripheral lesions.
“We are pleased to announce the first subjects enrolled into the Merit Medical WAVE study. Stent grafts have a proven track record in dialysis AV access, and we are excited to evaluate the WRAPSODY Stent Graft in our patients for this clinical trial,” said Jeffrey Hoggard, MD.
Over two million patients with kidney disease worldwide receive hemodialysis. Preferred long-term vascular access in these patients is generally achieved by the surgical creation of an arteriovenous fistula (AVF) or implantation of an arteriovenous graft (AVG)1. Vascular access circuit dysfunction is a common complication over time in AVFs and AVGs, accounting for
The WRAPSODY Endovascular Stent Graft is an investigational device with an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (ePTFE) and an internal layer of spun PTFE with an interposed non-porous fluoropolymer bonding layer.
The multicenter WAVE Study comparing the Merit WRAPSODY Endovascular Stent Graft to percutaneous transluminal angioplasty (PTA) for treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients plans to enroll 357 patients across multiple sites in the United States, Europe, Canada and New Zealand. The study has been designed to include a population of 244 patients with AVFs and 113 with AVGs. Merit intends to randomize treatment in patients with AVFs to the WRAPSODY Stent Graft or PTA and follow study subjects for two years post-procedure.
“We are pleased to announce the initiation of enrollment for our WAVE Study,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “The study has been designed to evaluate the safety and efficacy the WRAPSODY Endovascular Stent Graft for the treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients and represents an important step towards our goal of establishing the WRAPSODY as the standard of care for the more than two million patients suffering from kidney disease around the world.”
The WAVE Study follows successful completion of the WRAPSODY FIRST feasibility study which included 46 patients in Europe. The WRAPSODY system previously received the CE Mark and complements other vascular access products distributed by Merit, including the HeRO Graft and the Surfacer Inside-Out Access Catheter System.
Those interested in learning more about the WAVE Pivotal Study should 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 in excess of 300 individuals. Merit employs approximately 6,100 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s plans with respect to the WAVE Study and the potential impact, scope and duration of that study, 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, 2020 (the “2020 Annual Report”), Merit’s subsequent Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission (the “SEC”). Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s internal models or projections, including those related to the WAVE Study; risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; 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; negative changes in economic and industry conditions in the United States or other countries; expenditures relating to research, development, testing and regulatory approval or clearance of Merit’s products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental proceedings involving Merit; litigation and other judicial proceedings affecting Merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; actions of activist shareholders; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; increases in the prices of commodity components; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; termination or interruption of relationships with Merit’s suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referenced in the 2020 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. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this document are made only as of the date of this document, 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.
TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions.
- Vascular Access Work G. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006;48 Suppl 1:S176-247.
- Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996;7:523-535.
- Maya ID, Oser R, Saddekni S, Barker J, Allon M. Vascular access stenosis: Comparison of arteriovenous grafts and fistulas. American Journal of Kidney Diseases. 2004;44(5):859-865.
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FAQ
What is the WAVE Study initiated by Merit Medical (MMSI)?
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What is the primary focus of the WRAPSODY Endovascular Stent Graft?
What are the results of the previous feasibility study related to WRAPSODY?
