SOUTH JORDAN, Utah, July 05, 2022 (GLOBE NEWSWIRE) — Benefit Medical Methods, Inc. (NASDAQ: MMSI), a number one world producer and marketer of healthcare know-how, introduced immediately the profitable enrollment of the primary affected person in its WRAP Registry Examine. This examine will consider the medical advantages related to using the WRAPSODY Cell-Impermeable Endoprosthesis in sufferers receiving hemodialysis that have a narrowing (stenosis) or blockage (occlusion) of blood vessels required for dialysis (vascular entry).
Globally, over two million sufferers with superior kidney illness obtain dialysis.1 Hemodialysis, the first method used for dialysis, requires long-term vascular entry that’s usually achieved by way of the surgical creation of an arteriovenous fistula (AVF) or placement of an arteriovenous graft (AVG). Nevertheless, issues, comparable to stenosis and/or occlusion inside the dialysis outflow circuit of an AVF or AVG, can impair vascular entry which compromises the flexibility to offer enough dialysis therapy. The WRAPSODY Cell-Impermeable Endoprosthesis was created to assist overcome this problem by sustaining the integrity of the dialysis outflow circuit.
Dr. Dean Huang, advisor diagnostic and interventional radiologist at King’s Faculty Hospital in London, England, enrolled the primary affected person within the WRAP Registry. “The sufferers being handled with the WRAPSODY Cell-Impermeable Endoprosthesis have traditionally had few medical choices,” Dr. Huang stated. “These sufferers have usually confronted frequent reinterventions to take care of vessel patency leading to a number of procedures and hospitalizations. The WRAP examine will add to the rising physique of proof on WRAPSODY’s capacity to attain sturdy outcomes for this susceptible affected person inhabitants. We’re excited to enroll the primary affected person on this necessary examine.”
The WRAP Registry Examine will enroll as much as 500 sufferers with outflow circuit stenosis or occlusion who’re receiving hemodialysis at medical services all through Europe, South America, Australia, and New Zealand. Medical outcomes of sufferers after the preliminary placement of the WRAPSODY Cell-Impermeable Endoprosthesis shall be evaluated over a two-year interval in accordance with the directions to be used related to its CE Mark.
“Enrollment of the primary affected person within the WRAP Registry Examine will develop our medical portfolio of proof establishing the therapeutic advantages of the WRAPSODY Cell-Impermeable Endoprosthesis and supply real-world perception that may assist enhance the take care of sufferers receiving hemodialysis worldwide,” stated Fred P. Lampropoulos, Benefit Medical’s Chairman and CEO.
The WRAPSODY Cell-Impermeable Endoprosthesis is an expandable nitinol stent body absolutely enveloped by an exterior layer of expanded polytetrafluoroethylene (PTFE) and an inside layer of spun PTFE with an interposed cell-impermeable layer. The WRAPSODY Cell-Impermeable Endoprosthesis system is being studied below an Investigational Machine Exemption in the USA. It beforehand obtained the CE Mark and enhances different vascular entry merchandise distributed by Benefit Medical Methods, Inc., together with the HeROâ Graft, Tremendous HeRO® Adapter and Help Seal system, and CentrosFLOâ Hemodialysis Catheter.
WRAPSODY is just not authorized, cleared, or obtainable for industrial distribution in the USA and might not be authorized, cleared, or obtainable on the market or use in different international locations. For added info on the WRAP Registry Examine, together with ongoing updates, please go to https://www.clinicaltrials.gov/ct2/present/NCT05062291
ABOUT MERIT MEDICAL
Based in 1987, Benefit Medical Methods, Inc. is engaged within the improvement, manufacture, and distribution of proprietary disposable medical gadgets utilized in interventional, diagnostic, and therapeutic procedures, significantly in cardiology, radiology, oncology, vital care, and endoscopy. Benefit serves consumer hospitals worldwide with a home and worldwide gross sales power and medical assist crew totaling greater than 600 people. Benefit employs roughly 6,500 individuals worldwide.
Except famous in any other case, logos and registered logos used on this launch are the property of Benefit Medical Methods, Inc. and its subsidiaries in the USA and different jurisdictions.
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Mike Piccinino, CFA, IRC
Westwicke – ICR
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- Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. Lancet. 2015;385(9981):1975-82.