Gore granted conditional approval for studies

311

WL Gore & Associates has received conditional FDA approval to proceed with the Gore REVISE (VasculaR AccEss ReVision with GORE VIABAHN EndoproSthesis vs. PercutanEous Transluminal Angioplasty) study. 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).

The GORE VIABAHN Endoprosthesis devices used in the Gore REVISE study will feature the proprietary endpoint covalent bonding of heparin, similar to the recently launched GORE PROPATEN Vascular Graft used in AV access. 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.

Dr Tom Vesely, medical director on the Gore REVISE Study and an Interventional Radiologist at Vascular Access Center of Frontenac Grove, MO, commented: “The study is designed to demonstrate the clinical benefit of using a stent graft for AV graft revisions, rather than PTA alone. 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.”

AVIATOR study

The FDA has also granted conditional approval to proceed with the AVIATOR (Angioplasty vs. GORE VIABAHN Endoprosthesis Treatment Of GRaft Stenosis) study. This will be 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).

The GORE VIABAHN Endoprosthesis devices used in the AVIATOR study will feature the proprietary endpoint covalent bonding of heparin, (again, similar to the recently launched GORE PROPATEN Vascular Graft used in AV access)

Vesely added, “The study is designed to demonstrate the clinical benefit of using a stentgraft for AV graft revisions, rather than PTA alone. 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.”

Enrollment for both studies will begin in the third quarter of 2007.