A durable option for complex aortoiliac occlusive disease (AIOD)
Join the next generation of care with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surfacea,b (VIABAHN® Device).
5-year VBX Stent Graft follow-up
Decide with data
Previously, the 3-year Gore VBX FLEX Clinical Study follow-up found the VBX Stent Graft to be a robust and durable treatment option for AIOD.1 Now, sustained patient benefit and durability are demonstrated through 5 years.2
Investigator insights
Andrew Holden, MD, discusses the background, outcomes, and implications of this 5-year long-term data.
Physician-initiated 5-year VBX Stent Graft follow-up
Objective and methodology2
- This physician-initiated study enrolled 59 patients from 3 participating centers that were representative of the 3-year VBX FLEX Study follow-up cohort. Twenty-eight patients completed the 5-year follow-up.
- The primary durability end point was long-term primary patency.
DURABLE CLINICAL OUTCOMES THROUGH 5 YEARS2
primary patency per lesion
primary assisted patency per lesion
freedom from target lesion revascularization per subject
SUSTAINED PATIENT BENEFIT THROUGH 5 YEARS2
of patients improved ≥ 1 Rutherford category vs. baseline
.15
improvement in mean resting ankle-brachial index
3x
improvement in median Walking Impairment Questionnaire measures
Interested in more insights?
Hear more physician perspectives on the 5-year VBX Stent Graft follow-up.
The case for long-term durable clinical outcomes
Visit the VBX Stent Graft product page >
6 Fr compatible
GREATER VERSATILITY
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surfacea,b
Proven patency with unmatched versatilityc
VIABAHN® Device outcomes in iliac occlusive disease through 1 year
primary patency3
secondary patency3
freedom from target lesion revascularization3
Real-world, prospective, multicenter, single-arm study
- 100 patients treated for iliac artery occlusion or stenosis
- 10.2 cm mean lesion length
- 62% chronic total occlusion
- 71% TransAtlantic Inter-Society Consensus (TASC) C/D
- 37% chronic limb threatening ischemia
Rutherford classification and ankle-brachial index sustained improvement through 1 year, supporting durable clinical and perfusion benefits.3
Pain and mobility outcomes at 1 year
- 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 indications and configurations of covered stents.
- 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. J Endovasc Ther. 2020;27(5):728-736. doi:10.1177/1526602820920569
- Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliac occlusive disease treated with the VIABAHN VBX Balloon-Expandable Endoprosthesis. J Endovasc Ther. 2025;32(1):68-76. doi:10.1177/15266028231165723
- 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
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® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is also indicated for use with thoracoabdominal and pararenal branched devices indicated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a branch component.
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.
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.