First Patient Enrolled in Merit Medical's WRAPSODY (WRAP) North America Registry
- The WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE).
- The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN.
SOUTH JORDAN, Utah, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry.
The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience such obstructions. The study protocol provides for evaluation of clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, MD, President and Medical Director at Bluff City Vascular and Investigator in the WRAP North America registry, enrolled the first patient in the registry.
"We appreciate the ingenuity and novelty of the WRAPSODY CIE," said Dr. Davis. "Participation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients."
The superior performance of the WRAPSODY CIE in the clinical trial setting was previously demonstrated in the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial included two arms. In the randomized arm, patients with an arteriovenous fistula (AVF) were treated with the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA). In the non-randomized arm, clinical outcomes of patients with an arteriovenous graft (AVG) were compared to historical outcomes (i.e., performance goals) of AVG patients treated with previous-generation covered stents.
"The WRAPSODY CIE's ability to restore vascular access for patients on hemodialysis who experience obstructions is promising," said David J. Dexter II, MD, FACS, National Principal Investigator of the WRAP North America registry and Vascular Surgeon at Sentara Health Research Center in Norfolk, VA. "The opportunity to evaluate the WRAPSODY CIE's real-world effectiveness will help address critical questions regarding the broader impact of its use in clinical practice."
The WRAP North America registry is intended to add to Merit's growing portfolio of clinical evidence supporting the WRAPSODY CIE. If completed as designed, it would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.
"The first patient enrolled in the WRAP North America registry is an important milestone in our ongoing efforts to collect the highest quality of evidence regarding the WRAPSODY CIE's performance," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "Advancing technology that transforms lives through improved patient care is at the heart of what we do. Helping our physician partners shape the future of dialysis is both exciting and rewarding, and we look forward to seeing the difference that the WRAPSODY CIE makes in the lives of many patients."
Real-world outcomes associated with the use of the WRAPSODY CIE are also being evaluated in the WRAP Global registry, also being conducted by Merit, which was designed to enroll up to 500 patients outside of North America. Final enrollment in the WRAP Global registry is expected by the end of 2025.
For additional information on Merit's WRAP North America registry, please visit: https://clinicaltrials.gov/study/NCT06807099.
For additional information on Merit's WRAP Global registry, please visit: https://www.clinicaltrials.gov/ct2/show/NCT05062291.
On December 19, 2024, the WRAPSODY CIE received premarket approval from the US Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
For more information on the WRAPSODY CIE, please visit: https://www.merit.com/product/wrapsody-cie/.
Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission ("SEC"). For discussion of the risks and uncertainties which may affect Merit's business, operations and financial condition, see Part I, Item 1A, "Risk Factors" in Merit's Annual Report on Form 10-K for the year ended December 31, 2024, Part II, Item 1A, "Risk Factors" in Merit's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and Merit's other filings with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.
ABOUT MERIT
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 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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