Gore Announces First Patient Enrolled in Gore REVISE Clinical Study

IDE Study to Compare Performance of GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface to Percutaneous Transluminal Angioplasty (PTA)

The Gore REVISE (VasculaR AccEss ReVision with VIABAHN® EndoproSthesis vs PercutanEous Transluminal Angioplasty) Clinical Study enrolled its first patient on September 8, 2008 at Iowa Methodist Medical Center in Des Moines, IA. The procedure was performed by Andrew Nish, MD, an investigator for the Gore REVISE Clinical Study.

The Gore REVISE Clinical Study is a randomized, multi-center trial in the U.S. intended to establish efficacy and safety of the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous (AV) grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface and to percutaneous transluminal angioplasty (PTA). The study will involve approximately 280 subjects, 140 subjects in each treatment arm, at 30 sites.

According to Dr. Nish, “This study will provide the clinical community with valuable data on the performance of this heparin-bonded stent-graft for AV graft revisions, rather than PTA alone. The study is designed to show any difference in time between interventions when using stent grafts to treat venous outflow stenoses.”

“The study will provide further insight into addressing clinical issues in dialysis access patient populations” stated Susan Boothe, RN, MS, Product Specialist at Gore, who adds, “the fact that the study design permits the use of the device across the elbow joint makes this study unique.”

The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface is constructed with a durable, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner with a proprietary covalently bonded heparin surface, reinforced with an external nitinol stent structure. More than 90,000 GORE VIABAHN Endoprostheses have been implanted worldwide for various applications.