Open more possibilities with the GORE® VIABAHN® Endoprosthesis
Proven across a broad range of complex cases, the versatility of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*† enables you to deliver high patency and durable outcomes to minimize reinterventions. Consider the types of cases you treat and the challenges they present; the VIABAHN® Device helps you optimize clinical outcomes for your patients.
Not indicated for use in Canada.
Arteriovenous (AV) access
The VIABAHN® Device has proven success in the most challenging AV access cases, including early percutaneous transluminal angioplasty (PTA) failures, lesions at points of flexion, and in thrombosed grafts.
Designed to conform to challenging anatomy and proven to resist fractures‡
Demonstrated patency independent of the number of prior interventions1
Increased primary patency in thrombosed grafts of both the target lesion and the circuit when compared to PTA1
Superficial femoral artery (SFA)
The VIABAHN® Device delivers strong clinical performance in the most challenging cases with 80% average primary patency§ demonstrated across seven multicenter, prospective, randomized or single arm studies with an average lesion length of 23 cmII and 71% chronic total occlusions (CTOs).2-8
Comparable clinical results to above knee surgical bypass (both prosthetic and native vein)2,7
Excellent patency and durability independent of lesion length2-6
In-stent restenosis (ISR) of the SFA
The VIABAHN® Device provides durable treatment for complex in-stent restenotic lesions.
Ability to cover and seal disease, leading to durable outcomes in long, complex ISR
The VIABAHN® Device is the only self-expanding stent graft indicated to treat stenotic iliac lesions.
The GORE® VIABAHN® Device family has demonstrated patency that approaches surgical bypass.10-12
Not indicated for use in U.S.
Popliteal artery aneurysm (PAA)
The VIABAHN® Device shows strong clinical performance in challenging PAA cases.
Endovascular repair of popliteal aneurysms is associated with acceptable long-term patency and a very low risk of limb loss.11
* As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
† Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions.
‡ Across all uses, the GORE® VIABAHN® Endoprosthesis has a reported fracture rate of < .015% (data on file 2018; W. L. Gore & Associates, Inc; Flagstaff, AZ.)
§ One-year weighted average primary patency.
II Weighted average lesion length.
1. 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. Journal of Vascular Surgery 2016;64(5):1400-1410.e1. http://www.sciencedirect.com/science/article/pii/S0741521416301756
2. Reijnen M, van Walraven L, Fritschy W, et al. 1-year results of a multicenter, randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. Journal of Cardiovascular Interventions 2107;10(22):2320-2331.
3. 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. Journal of Vascular Surgery 2021;74(6):1958-1967.e2.
4. 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-bonded Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) Trial. Journal of Vascular & Interventional Radiology 2013;24(2):165-173.
5. 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. Cardiovascular & Interventional Radiology 2015;38(1):25-32.
6. Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm Trial. Journal of Endovascular Therapy 2014;21(6):765-774.
7. Iida 0. Twelve-month outcomes from the Japanese post-market surveillance study of the GORE® VIABAHN® Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. Presented at LEIPZIG Interventional Course (LINC)2021; January 25-29, 2021; Leipzig, Germany.
8. Iida O, Takahara M, Soga Y, et al; VANQUISH Investigators. One-year outcomes of heparin-bonded stent-graft therapy for real-world femoropopliteal lesions and the association of patency with the prothrombotic state based on the prospective, observational, multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study. Journal of Endovascular Therapy 2021;28(1):123-131.
9. 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.
10. Lammer J, Dake M.D., Bleyn J, et al. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent graft. Radiology 2000;217(1):95-104.
11. Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal study of a next-generation balloon-expandable stent-graft for treatment of iliac occlusive disease. Journal of Endovascular Therapy 2017;24(5):629-637. http://journals.sagepub.com/doi/full/10.1177/1526602817720463
12. Indes JE, Pfaff MJ, Farrokhyar F, et al. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and meta-analysis. Journal of Endovascular Therapy 2013;20(4):443-455.
13. Golchehr B, Zeebregts CJ, Reijnen MMPJ, Tielliu IFJ. Long-term outcome of endovascular popliteal artery aneurysm repair. Journal of Vascular Surgery 2018;67(6):1797-1804.
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.