Flagstaff, AZ (September 17, 2008)–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.
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.
Erik Clausen or Courtney Smith
Schwartz Communications, Inc. for W. L. Gore & Associates
415-512-0770 or 781-684-0770
GoreMedical@schwartz-pr.com
Products listed may not be available in all markets pending regulatory clearance. GORE, PROPATEN, and VIABAHN® are trademarks of W. L. Gore & Associates.