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.
The GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will be used in the Gore REVISE Study, featuring the proprietary end-point covalent bonding of heparin, similar to the recently launched GORE PROPATEN Vascular Graft used in dialysis access. "We are excited to continue striving toward solutions for clinical issues in dialysis access patient populations, states Susan Boothe, RN, MS, Gore Product Specialist. "We anticipate study enrollment to begin in Spring 2008.
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. Worldwide, more than 90,000 GORE VIABAHN® Endoprostheses have been implanted.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com.
GORE, PROPATEN and VIABAHN® are trademarks of W. L. Gore & Associates. AM0644-EN1