Consider the challenges of treating complex iliac lesions

  • Multicenter and prospective studies demonstrate suboptimal performance of bare metal stent (BMS) in complex iliac disease.1-6
    • In the COBEST Trial, the 5-year primary patency of BMS in TASC II C & D lesions was approximately 25%.1
  • Perforation/rupture of the iliac arteries and aortic bifurcation is not uncommon and can be life-threatening.7,8
    • In the presence of severe calcification, surgery guidelines recommend stent graft placement for treatment of iliac occlusive disease (IOD).9 
Kaplan-meier curve of primary patency for TASC II C/D lesion
The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* (VIABAHN® Device) and the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) have been proven to address the treatment challenges in complex IOD.

 

Demonstrated durability

  • Stent grafts have demonstrated superiority over BMS for treating complex iliac lesions.5,6
    • Self-expanding stent grafts, at three years, have demonstrated improved patency over BMS when treating TASC II D iliac lesions.5  
    • Balloon expandable stent grafts, through five years, have demonstrated higher primary patency compared to BMS.1 

Proven patency

  • The VIABAHN® Device family has patency rates that approaches published surgical bypass results.  
    • The VIABAHN® Device has demonstrated 89.8% 3-year primary patency.10
    • The VBX Stent Graft has demonstrated 94.5% 1-year primary patency.11
    • Meta-analysis review of 3,733 open bypass patients across 29 studies demonstrated pooled primary patency of 95%.8 

Based on prior clinical data. New evaluation of reduced profile delivery is underway.  

* As used by Gore, PROPATEN Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface. 

1. Mwipatayi BP, Sharma S, Daneshmand A, et al; COBEST co-investigators.  Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.  Journal of Vascular Surgery 2016;64(1):83-94.e1.

2. Mwipatayi BP, Thomas S, Wong J, et al; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigators.  A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease.  Journal of Vascular Surgery 2011;54(6):1561-1570.  

3. Sabri SS, Choudhri A, Orgera G, et al.  Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation.  Journal of Vascular & Interventional Radiology 2010;21(7):995-1003.

4. Piazza M, Squizzato F, Spolverato G, et al.  Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions.  Journal of Vascular Surgery 2015;62(5):1210-1218.e1

5. Piazza M, Squizzato F, Dall’Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185.

6. Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ. Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. Journal of Vascular Surgery 2008;48(2):362-367.

7. Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. Journal of Vascular Surgery 2010;52(5):1376-1383.  

8. 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.  

9. Society for Vascular Surgery Lower Extremity Guidelines Writing Group; Conte MS, Pomposelli FB, et al; Society for Vascular Surgery. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease and claudication. Journal of Vascular Surgery 2015;61(3)Supplement: 2S-41S.e1.

10. Squizzato, F., Mosquera-Rey, V., Zanabili Al-Sibbai, A. et al. Outcomes of Self-Expanding Covered Stents for the Treatment of External ILIAC Artery Obstructive Disease. Cardiovasc Intervent Radiol 46, 579–587 (2023).

11. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736. https://journals.sagepub.com/doi/10.1177/1526602820920569

12. GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed September 17, 2024. https://eifu.goremedical.com 

13. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Instructions for Use (IFU).  W. L. Gore & Associates, Inc. Accessed July 10, 2025. https://eifu.goremedical.com 

IFU Consult instructions

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

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface:

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:

  • de novo or restenotic lesions in the iliac arteries
  • de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
  • popliteal artery aneurysms and isolated visceral artery aneurysms
  • traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries)

CONTRAINDICATIONS:

  • 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 PROPATEN 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.


GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis:

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:  

  • de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;    
  • de novo or restenotic lesions in the visceral arteries;    
  • Isolated visceral, iliac, and subclavian artery aneurysms; or  
  • Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).  

The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for use as a bridging stent in branched and fenestrated endovascular aortic aneurysm repair with the following:  

  • Approved for use branched aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and polypropylene suture with branch diameters of 6/8 mm and lengths of 18/21 mm.  
  • Approved for use fenestrated aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and fenestrations with polypropylene suture ranging in diameter from 6–8 mm.  

CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 

 

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile)

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:

  • de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;
  • de novo or restenotic lesions in the visceral arteries;
  • isolated visceral, iliac, and subclavian artery aneurysms; or
  • traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).

CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.

Product may not be available in all countries. Please check with your Gore representative for availability.
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