Merit Medical's WRAPSODY WAVE Trial Exceeds Performance Goals for Arteriovenous Graft (AVG) Patients
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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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.
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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 [email protected] 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).
