Prospective, international, multicenter, observational study to assess the real-world safety and efficacy of the WRAPSODY Cell-Impermeable Endoprosthesis
SOUTH JORDAN, Utah, July 5, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the successful enrollment of the first patient in its WRAP Registry Study. This study will evaluate the clinical benefits associated with the use of the WRAPSODY Cell-Impermeable Endoprosthesis in patients receiving hemodialysis that experience a narrowing (stenosis) or blockage (occlusion) of blood vessels required for dialysis (vascular access).
Globally, over two million patients with advanced kidney disease receive dialysis.1 Hemodialysis, the primary approach used for dialysis, requires long-term vascular access that is typically achieved through the surgical creation of an arteriovenous fistula (AVF) or placement of an arteriovenous graft (AVG). However, complications, such as stenosis and/or occlusion within the dialysis outflow circuit of an AVF or AVG, can impair vascular access which compromises the ability to provide adequate dialysis treatment. The WRAPSODY Cell-Impermeable Endoprosthesis was created to help overcome this challenge by maintaining the integrity of the dialysis outflow circuit.
Dr. Dean Huang, consultant diagnostic and interventional radiologist at King’s College Hospital in London, England, enrolled the first patient in the WRAP Registry. “The patients being treated with the WRAPSODY Cell-Impermeable Endoprosthesis have historically had few clinical options,” Dr. Huang said. “These patients have typically faced frequent reinterventions to maintain vessel patency resulting in multiple procedures and hospitalizations. The WRAP study will add to the growing body of evidence on WRAPSODY’s ability to achieve durable outcomes for this vulnerable patient population. We are excited to enroll the first patient in this important study.”
The WRAP Registry Study will enroll up to 500 patients with outflow circuit stenosis or occlusion who are receiving hemodialysis at medical facilities throughout Europe, South America, Australia, and New Zealand. Clinical outcomes of patients after the initial placement of the WRAPSODY Cell-Impermeable Endoprosthesis will be evaluated over a two-year period in accordance with the instructions for use associated with its CE Mark.
“Enrollment of the first patient in the WRAP Registry Study will expand our clinical portfolio of evidence establishing the therapeutic benefits of the WRAPSODY Cell-Impermeable Endoprosthesis and provide real-world insight that can help improve the care for patients receiving hemodialysis worldwide,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO.
The WRAPSODY Cell-Impermeable Endoprosthesis is an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (PTFE) and an internal layer of spun PTFE with an interposed cell-impermeable layer. The WRAPSODY Cell-Impermeable Endoprosthesis system is being studied under an Investigational Device Exemption in the United States. It previously received the CE Mark and complements other vascular access products distributed by Merit Medical Systems, Inc., including the HeRO® Graft, Super HeRO® Adapter and Support Seal system, and CentrosFLO® Hemodialysis Catheter.
WRAPSODY 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. For additional information on the WRAP Registry Study, including ongoing updates, please visit https://www.clinicaltrials.gov/ct2/show/NCT05062291
ABOUT MERIT MEDICAL
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 600 individuals. Merit employs approximately 6,500 people worldwide.
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- Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. Lancet. 2015;385(9981):1975-82.