First Sufferers Enrolled within the Benefit WRAPSODY AV Entry Efficacy Pivotal Examine
“We’re happy to announce the primary topics enrolled within the Benefit Medical WAVE examine. Grafted stents have a confirmed observe file for dialysis AV entry, and we’re delighted to be evaluating the WRAPSODY Stent Grafting in our sufferers for this medical trial, ”stated Jeffrey Hoggard, MD.
Greater than two million sufferers with kidney failure worldwide obtain hemodialysis. The popular long-term vascular entry in these sufferers is normally achieved by the surgical creation of an arteriovenous fistula (AVF) or the implantation of an arteriovenous graft (AVG).1. Vascular entry circuit dysfunction is a typical complication over time in AVF and AVG, accounting for 20% of hospitalizations in sufferers with end-stage renal illness2. Stenosis or occlusion of those vascular entry circuits is extra widespread within the venous outflow section3.
The WRAPSODY Endovascular Stent Graft is an experimental system with an expandable nitinol stent body totally enveloped by an outer layer of expanded polytetrafluoroethylene (ePTFE) and an interior layer of spun PTFE with a non-porous fluoropolymer tie layer interposed.
The multi-center WAVE examine evaluating the Benefit WRAPSODY stent graft to percutaneous transluminal angioplasty (PTA) for the therapy of stenosis or occlusion of the venous outflow circuit in hemodialysis sufferers plans to enroll 357 sufferers at a number of websites at United States, Europe, Canada and New Zealand. The examine was designed to incorporate a inhabitants of 244 sufferers with AVF and 113 with AVG. Benefit intends to randomize therapy of sufferers with AVF to the WRAPSODY or PTA stent graft and to comply with examine topics for 2 years after the process.
“We’re happy to announce the launch of enrollment in our WAVE examine,” stated Fred P. Lampropoulos, President and CEO of Benefit Medical. “The examine was designed to evaluate the protection and efficacy of WRAPSODY Endovascular Stent Graft for the therapy of venous outflow stenosis or occlusion in hemodialysis sufferers and represents an necessary step in direction of our purpose. to ascertain WRAPSODY as the usual of take care of the greater than two million sufferers with kidney illness worldwide. “
The WAVE examine follows the profitable WRAPSODY FIRST feasibility examine which included 46 sufferers in Europe. The WRAPSODY System has beforehand been CE marked and enhances different vascular entry merchandise distributed by Benefit, together with the HeRO Graft and the Surfacer Inside-Exterior Entry Catheter System.
These serious about studying extra in regards to the WAVE pivotal examine ought to go to:
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, notably in cardiology, radiology, oncology, intensive care and endoscopy. Benefit serves consumer hospitals around the globe with a nationwide and worldwide gross sales pressure and medical assist crew totaling over 300 individuals. Benefit employs roughly 6,100 individuals worldwide with services in southern Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, the Netherlands; Paris, France; Galway, Eire; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Studying, United Kingdom; Johannesburg, South Africa; and Singapore.
- Work on vascular entry G. Scientific follow tips for vascular entry. Am J Kidney Dis. 2006; 48 Suppl 1: S176-247.
- Feldman HI, Kobrin S, Wasserstein A. Morbidity of vascular entry by hemodialysis. J Am Soc Nephrol. 1996; 7: 523-535.
- Maya ID, Oser R, Saddekni S, Barker J, Allon M. Vascular entry stenosis: Comparability of arteriovenous grafts and fistulas. American Journal of Kidney Illness. 2004; 44 (5): 859-865.