Merit Medical’s WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment
SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) to percutaneous transluminal angioplasty for treatment of stenosis/occlusion in the venous outflow circuit in patients undergoing hemodialysis.
Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access (access to blood vessels) is required for patients undergoing hemodialysis. However, progressive stenosis (narrowing) and/or occlusion (blockage) of blood vessels where the AVF and AVG are located can prevent delivery of hemodialysis, which can have life-threatening consequences. WRAPSODY was developed to help physicians treat patients with stenosis/occlusion in the vessels used for hemodialysis.
The WAVE study enrolled 244 patients with AVFs and 113 patients with AVGs across sites in Brazil, Canada, the United Kingdom, and the United States. Merit intends to collect safety and efficacy outcomes throughout the study follow-up period. Merit anticipates filing primary outcomes with the U.S. Food and Drug Administration (FDA) for Premarket Approval (PMA) after six months post-enrollment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.
“Given the inadequacy of therapeutic options to maintain vascular access in hemodialysis patients, understanding WRAPSODY’s overall performance—due to its unique cell-impermeable stent covering in helping to maintain AV fistulas and grafts—is of high value to physicians and the scientific community,” says Mahmood K. Razavi, MD, FSIR, FSVM, medical director of clinical research at St. Joseph Heart and Vascular Center in Orange, Calif., co-principal investigator of the WAVE study, and paid consultant of Merit.
“The WAVE study has now completed the anticipated recruitment thanks to the patients that participated and to the hard work of all the global investigators and their respective teams,” says Rob Jones, MBChB, MRCP, FRCR, consultant interventional radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, co-principal investigator of the WAVE study, and paid consultant of Merit. “I am looking forward to the data analysis and the next step in this device’s journey in providing definitive management to AV access patients.”
“Enrollment of the last patients in the WAVE study represents an important milestone,” says Fred P. Lampropoulos, Merit’s Chairman and CEO. “We believe it will enable us to provide critical insight to our physician partners and support our submission of a PMA Application to the Food and Drug Administration.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not approved, cleared, or available for commercial distribution in the United States and may not be approved, cleared, or available for sale or use in other countries. In the United States, the device is being used under an Investigational Device Exemption (IDE) from the Food and Drug Administration. Findings from the WAVE study are expected to expand on results from the first-in-human study (WRAPSODY FIRST) and support the Premarket Approval (PMA) application to the FDA for commercial use in the United States. The WRAPSODY 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’s WAVE study, please visit ClinicalTrials.gov here.
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 700 individuals. Merit employs approximately 7,100 people worldwide.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s anticipated plans with respect to, or the regulatory, therapeutic, commercial or other implications of, Merit’s WAVE 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, 2022 (the “2022 Annual Report”) and other filings with the SEC. Such risks and uncertainties include risks and uncertainties relating to Merit’s expectations, forecasts or projections referenced in this release; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components and other raw materials; adverse changes in freight, shipping and transportation expenses; negative changes in economic and industry conditions in the United States or other countries, including inflation; risks relating to Merit’s potential inability to successfully manage growth through acquisitions, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; risks associated with Merit’s ongoing or prospective manufacturing transfers and facility consolidations; fluctuations in interest or foreign currency exchange rates; 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; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; consequences associated with a Corporate Integrity Agreement executed between Merit and the U.S. Office of Inspector General; 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 Medical Device Regulation, and risks that such products may not be developed successfully or approved for commercial use; litigation and other judicial proceedings affecting Merit; 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; 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; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; 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 jurisdictions; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; 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; dependance on distributors to commercialize Merit’s products in various jurisdictions outside the United States; 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; failure to introduce products in a timely fashion; price and product competition; fluctuations in and obsolescence of inventory; and risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; and other factors referenced in the 2022 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 or any other forward-looking statements.
TRADEMARKS
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