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 were presented at the Vascular Interventional Advances 2016 (VIVA) Conference. 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 Study2 has once again proven that the VIABAHN® device 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.
* Data on file.
** 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.
- W. L. Gore & Associates. Multi-center study for stent graft system for peripheral artery (VJH 11-01). Bethesda, MD: National Library of Medicine; 2012. Available from: https://clinicaltrials.gov/ct2/show/NCT01575808. NLM Identifier: NCT01575808. Published April 9, 2012. Updated June 9, 2015. Accessed May 10, 2016.