Gore completes enrollment in study of VIABAHN Endoprosthesis with Heparin Bioactive Surface

W. L. Gore & Associates (Gore) reported the complete enrollment in a post-market approval study designed to better characterize the performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in treating peripheral vascular disease (PVD) of the superficial femoral artery (SFA). The 11 participating sites enrolled a total of 120 patients in the Gore VIPER (GORE^® VIABAHN^® Endoprosthesis with Heparin Bioactive Surface for SuPERficial Femoral Artery Endoluminal Bypass) Study since initiation.

“Speaking for the Gore VIPER investigators, we are pleased to have completed enrollment and are enthusiastic about determining the results”

Forty patients were treated with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface alone, while the remaining 80 patients were treated with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface manufactured with the proximal contoured edge. The contoured edge resulted from a manufacturing process change and may improve flow dynamics at the inlet of the device in conditions of over-sizing. The follow-up for the Gore VIPER Study includes patency and target lesion revascularization rates evaluated at 12 months. While the GORE VIABAHN Endoprosthesis was originally approved for treating SFA obstructive disease in the U.S. in 2005, the VIPER study comprises the first multi-center evaluation of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, which was introduced in the U.S. in 2007.

"Speaking for the Gore VIPER investigators, we are pleased to have completed enrollment and are enthusiastic about determining the results," said Richard Saxon, M.D., FSIR, Director of Research for the San Diego Cardiac and Vascular Institute and North County Radiology Medical Group in Oceanside, CA, and principal investigator for the Gore VIPER Study. "SFA studies like Gore VIPER help us to determine the best endovascular treatment options for our patients suffering from atherosclerotic occlusive disease. Although many studies fail to include longer lesions, average lesion length treated in the Gore VIPER Study was approximately 18 cm, so we are definitely capturing a challenging, real-world experience. Moreover, having both patients with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface alone as well as patients treated with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface manufactured with the proximal contoured edge will hopefully give us some insight into the clinical impact of the contoured edge device."

Arun Chervu, M.D., of Wellstar Cobb Hospital, Atlanta, GA and a leading enroller in the VIPER Study, stated, "The intent of the study was to initiate a post-market evaluation of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of long SFA disease. Our center has used the device to cover lesions up to 40 cm in length and we look forward to understanding how the device performs in these challenging clinical circumstances."