WRAPSODY achieves 82% target lesion primary patency at six months in the single-arm cohort of the US pivotal trial
SOUTH JORDAN, Utah, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced positive six-month findings from the single-arm AVG cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were presented at the 51st annual VEITHsymposium during the Novel Technologies in Hemodialysis Access session.
An AVG is a synthetic tube that is used for long-term access to blood vessels for patients undergoing hemodialysis. However, over time, the graft may become narrow or blocked, resulting in potentially life-threatening consequences. Merit’s WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore and extend vessel access (patency) in hemodialysis patients, which is critical for patient survival.
The WAVE trial was designed to evaluate the efficacy and safety of the WRAPSODY device. The AVG arm of the WAVE trial enrolled 112 patients across 43 international sites. All enrolled patients were treated with the WRAPSODY device. Based on survival analysis through six months, target lesion and access circuit primary patency for AVG patients in the WAVE trial were 82% and 68.8%, respectively. Primary efficacy1 and safety2 endpoints were assessed by comparing actual rates for the WRAPSODY device to performance goals (PG) for covered stents (efficacy PG: 60%; safety PG: 89%). Efficacy of the WRAPSODY device was 81.4%, which is 21.4 percentage points higher than the PG of 60% (p<0.0001). The proportion of AVG patients who were free from an adverse event was higher than the safety PG (95.4% vs. 89.0%, p=0.0162).
“In light of the historically low patency rates for AVG patients, the positive results from the AVG arm of the WAVE trial are very encouraging for physicians who manage these patients,” 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.
“The patency results from the WAVE trial are the highest that I have seen to date and are expected to meaningfully improve patients’ quality of life and vascular access survival,” said Leonardo Harduin, MSc, Vascular Surgeon at University of Rio de Janeiro State in Rio de Janeiro, Brazil, and an Investigator of the WAVE trial. “These results will probably have a positive impact on costs related to the care of these patients.”
“At Merit, we remain committed to continued collaboration with our physician partners to improve care for hemodialysis patients. Over the past year we have expanded our product offering and focus on these patients. The WRAPSODY device is an important part of this growing portfolio,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are pleased to have the opportunity to share the favorable primary outcomes from the WAVE trial at VEITHsymposium.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not approved or available for commercial distribution in the United States and may not be approved 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 US Food and Drug Administration (FDA). Findings from the WAVE trial expand on results from the first-in-human trial (WRAPSODY FIRST) and support the Premarket Approval (PMA) application to the FDA for commercial use in the United States. The device is available in Brazil and in the European Union. For additional information on Merit Medical’s WAVE trial, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302.
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Statements contained in this release which are not purely historical, including, without limitation, statements regarding anticipated results, outcomes and applications of clinical trials, studies and investigations involving Merit’s products, safety, efficacy and patient and physician adoption of Merit’s products, Merit’s ability to procure and 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 the 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.
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ABOUT MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,200 people worldwide.
ABOUT VEITHSYMPOSIUM
Now in its 51st year, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The five-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. Contact Pauline T. Mayer at 631.807.6335 or ptm@ptmhcm.com for additional information.
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1 The primary efficacy outcome was defined as the proportion of patients free from clinically driven target lesion revascularization or target lesion thrombosis through six months.
2 The primary safety outcome was the proportion of patients without any localized or systemic adverse events in the 30 days following treatment that negatively affected the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).
