The GORE® VIABAHN® Endoprosthesis has an extremely strong, growing body of clinical data in the category of complex SFA lesions.
Positive results from a prospective, multicenter Investigational Device Exemption (IDE) Clinical Study of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface* in Japan have been published by the Journal of Vascular Surgery. The study demonstrated:
- 88% 12-month primary patency in long, complex SFA lesions (n = 103)1
- 21.8 cm average lesion length
- 65.7% chronic total occlusions (CTOs)
- 84.5% TASC II C&D lesions
The Gore Japan IDE Clinical Study** has once again proven that the GORE® VIABAHN® Endoprosthesis effectively covers and seals off diseased tissue, enabling high patencies regardless of lesion length. This clinical study demonstrates that endoluminal bypass continues to be an essential component of a physician’s toolkit for treating complex SFA disease.
The Gore Japan IDE Clinical Study is now the fourth prospective, multicenter trial to study performance of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface* in complex de novo and restenotic SFA disease.
* Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface.
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no Target Lesion Revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without a TLR.
- Ohki T, Kichikawa K, Yokoi H, et al. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. Journal of Vascular Surgery. http://www.sciencedirect.com/science/article/pii/S074152141730383X