GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surfacea,b Clinical Data
Open more possibilities with the VIABAHN® Device
Proven across a broad range of complex cases1, the versatility of the VIABAHN® Device enables you to deliver high patency and durable outcomes to minimize reinterventions.2-4
Consider the types of cases you treat and the challenges present. The VIABAHN® Device helps you optimize clinical outcomes for your patients.
AV access
The VIABAHN® Device has proven success in the most challenging arteriovenous (AV) access cases, including early percutaneous transluminal angioplasty (PTA) failures, lesions at points of flexion and thrombosed grafts.4
New 1-year clinical data across AV access lesions
Review recently published 1-year clinical outcomes from a Japan-based study evaluating VIABAHN® Device performance across AV graft lesions in stenotic and thrombosed AV grafts.
Increased primary patency in thrombosed grafts of both the target lesion and the circuit when compared to PTA4
Superficial femoral artery (SFA)
The VIABAHN® Device delivers strong clinical performance in the most challenging cases with 80% average primary patencyc demonstrated across 7 multicenter, prospective, randomized or single-arm studies with an average lesion length of 23 cmd and 71% chronic total occlusions.5
Comparable clinical results to above-knee surgical bypass (both prosthetic and native vein)6,7
Comparable clinical results to above-knee surgical bypass (both prosthetic and native vein)6,7 with excellent patency and durability independent of lesion length8-10
Iliac Artery
The VIABAHN® Device is the only self-expanding stent graft indicated to treat stenotic iliac lesions.
VIABAHN® Device Family clinical data in AIOD
Explore consolidated clinical evidence showing how the VIABAHN® Device Family — including the VBX Stent Graft — performs in the treatment of aortoiliac occlusive disease (AIOD).
Publications
Discover current publications and clinical data demonstrating the utility of the VIABAHN® Device in practice.
Soukas P, Becker M, Stark K, Tepe G; RELINE MAX Investigators. Three-year results of the GORE VIABAHN Endoprosthesis in the superficial femoral artery for in-stent restenosis. J Soc Cardiovasc Angiogr Interv. 2023;2(3):100598. doi:10.1016/j.jscai.2023.100598
Haruguchi H, Fukasawa M, Ikeda K, et al. Treatment with a self-expanding endoprosthesis in patients with stenosis or occlusion at the arteriovenous graft: 6-month outcomes of a post-marketing surveillance study. J Vasc Access. 2025;26(6):1829-1837. doi:10.1177/11297298241286249
Fukasawa M, Haruguchi H. A 1-year follow-up analysis of a post-market surveillance study of a self-expanding endoprosthesis for stenosis or occlusion at the arteriovenous access. J Vasc Access. 2026;27(1):169-175. doi:10.1177/11297298251330951
Reijnen MMPJ, Mezes P, Tigkiropoulos K. One-year clinical outcomes of a self-expanding covered stent for aortoiliac occlusive disease. J Endovasc Ther. 2025:15266028251399582. doi:10.1177/15266028251399582
Iida O, Ohki T, Soga Y, et al. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024;29(4):416-423. doi:10.1177/1358863X241233528
Iida O, Ohki T, Soga Y, et al. Twelve-month outcomes from the Japanese post-market surveillance study of the VIABAHN Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. J Endovasc Ther. 2022;29(6):855-865. doi:10.1177/15266028211067739
Ohki T, Kichikawa K, Yokoi H, et al. Long-term results of the Japanese multicenter VIABAHN trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery. J Vasc Surg. 2021;74(6):1958-1967.e2. doi:10.1016/j.jvs.2021.05.056
Bosiers M, Deloose K, Callaert J, et al. Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial. J Cardiovasc Surg (Torino). 2020;61(5):617-625. doi:10.23736/S0021-9509.20.11382-X
Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus VIABAHN Stent Graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64(5):1400-1410.e1. doi:10.1016/j.jvs.2016.04.035
Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and economic benefits of stent grafts in dysfunctional and thrombosed hemodialysis access graft circuits in the REVISE randomized trial. J Vasc Interv Radiol. 2019;30(2):203-211.e4. doi:10.1016/j.jvir.2018.12.006
Ohki T, Kichikawa K, Yokoi H, et al. Outcomes of the Japanese multicenter VIABAHN Trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg. 2017;66(1):130-142.e1. doi:10.1016/j.jvs.2017.01.065
Reijnen MMPJ, van Walraven LA, Fritschy WM, et al. 1-year results of a multicenter randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. JACC Cardiovasc Interv. 2017;10(22):2320-2331. doi:10.1016/j.jcin.2017.09.013
Lammer J, Zeller T, Hausegger KA, et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol. 2015;38(1):25-32. doi:10.1007/s00270-014-1024-9
Saxon RR, Chervu A, Jones PA, et al. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of superficial femoral artery obstructive disease) trial. J Vasc Interv Radiol. 2013;24(2):165-173. doi:10.1016/j.jvir.2012.10.004
a. As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
b. Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions.
c. One-year weighted average primary patency.
d. Weighted average lesion length.
- GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed Jun 30, 2026 https://eifu.goremedical.com/
- Soukas P, Becker M, Stark K, Tepe G; RELINE MAX Investigators. Three-year results of the GORE VIABAHN Endoprosthesis in the superficial femoral artery for in-stent restenosis. J Soc Cardiovasc Angiogr Interv. 2023;2(3):100598. doi:10.1016/j.jscai.2023.100598
- Iida O, Ohki T, Soga Y, et al. Five-Year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese post-market surveillance study. Vascular Medicine 2024;29(4):416-423. Presented at the 21st Annual Vascular InterVentional Advances (VIVA); October 30, 2023-November 2, 2023; Las Vegas, NV.
- Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus VIABAHN Stent Graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64(5):1400-1410.e1. doi:10.1016/j.jvs.2016.04.035. OPEN ACCESS http://www.sciencedirect.com/science/article/pii/S0741521416301756
- Data on file. W. L. Gore & Associates; YEAR. Data summary of multicenter studies.
- Reijnen MMPJ, van Walraven LA, Fritschy WM, et al. 1-year results of a multicenter randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. JACC Cardiovasc Interv. 2017;10(22):2320-2331. doi:10.1016/j.jcin.2017.09.013
- McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. Journal of Vascular Surgery 2010;52(3):584-591.
- Iida O, Ohki T, Soga Y, et al. Twelve-month outcomes from the Japanese post-market surveillance study of the VIABAHN Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. J Endovasc Ther. 2022;29(6):855-865. doi:10.1177/15266028211067739
- Saxon RR, Chervu A, Jones PA, et al. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of superficial femoral artery obstructive disease) trial. J Vasc Interv Radiol. 2013;24(2):165-173. doi:10.1016/j.jvir.2012.10.004
- Lammer J, Zeller T, Hausegger KA, et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol. 2015;38(1):25-32. doi:10.1007/s00270-014-1024-9
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INDICATIONS FOR USE IN THE US: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts.
CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.