In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months.
SOUTH JORDAN, Utah, May 05, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced that the 12-month results from the single-arm cohort of the WAVE trial were presented at the annual Charing Cross Symposium held in London, England, on April 23, 2025, during the Vascular Access Masterclass session. Following the scientific podium presentation, results were presented during a Merit-sponsored symposium.
The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy performance goal for covered stents. At 6 months, the TLPP associated with the WRAPSODY CIE was 81.4%, a result 21.4 percentage points higher than the performance goal of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety performance goal (95.4% vs. 89.0%, p=0.016). At 12 months, the TLPP associated with the WRAPSODY CIE was 60.2%. Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2%, respectively.
“Patients with a failing AVG have limited options available to restore functionality of their access,” said Robert G. Jones, MBChB, FRCR, Consultant Interventional Radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, and Co-Principal Investigator of the WAVE trial. “Therefore, it was exciting to present findings to my colleagues, so they are aware of WRAPSODY’s potential to improve care for this vulnerable patient population.”
“We are pleased to have the opportunity to share the positive findings of WRAPSODY with our physician partners, and we look forward to working with them to improve patient outcomes,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.
Twelve-month findings from the randomized arm of the WAVE trial (TLPP: 70.1%; ACPP: 58.1%) were previously presented at the annual Society of Interventional Radiology meeting held in Nashville, TN. Six-month efficacy results (TLPP: 89.8%; ACPP: 72.6%) were published in Kidney International.
The Merit WRAPSODY CIE is available in Brazil and in the European Union and is approved for commercial distribution in the United States. For additional information on Merit Medical’s WAVE study, 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 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 800 individuals. Merit employs approximately 7,300 people worldwide.
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