Gore Revise Study Receives Approval from FDA

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--FDA approval to proceed with the Gore REVISE (VasculaR AccEss ReVision with Viabahn® EndoproSthesis vs PercutanEous Transluminal Angioplasty) Study was announced today by W. L. Gore & Associates (Gore). The Gore REVISE Study is a randomized, multi-center clinical trial intended to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the GORE VIABAHN® Endoprosthesis and to percutaneous transluminal angioplasty (PTA).
Tom Vesely, MD, Medical Director on the Gore REVISE Study and an Interventional Radiologist at Vascular Access Center in Frontenac Grove, Mo., states, “The study is designed to demonstrate the clinical benefit of using a stent-graft for AV graft revisions, rather than PTA alone.” Dr. Vesely continues, “With a focus on target-lesion primary patency, the study is designed to show an increased amount of time between interventions in dialysis access grafts.”
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