GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Designed to expand to every demand, the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) offers proven procedural success and long-term outcomes1-3 through flexibility, strength and accuracy to treat aortoiliac occlusive disease.
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is not authorized for use with thoracoabdominal and pararenal branched devices indicated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a branch component in Canada.
Trusted performance. Unmatched versatility.*
Improvements to the device delivery system have enabled a 1 Fr profile reduction on the majority of sizes, now offering the most 6 Fr compatible configurations among balloon expandable stent grafts.4-7
Now 6 Fr compatible
GREATER VERSATILITY
UP TO 79 mm
stent length4-7
Darren Schneider, M.D., Andrew Holden, M.D., Bill Gray, M.D. and Venita Chandra, M.D. discuss benefits of the reduced profile VBX Stent Graft.
Trusted procedural and clinical performance
100% restoration
of lumen diameter2
≤ 30% residual stenosis due to high radial strength, even in highly calcified and non-compliant lesions
100%
maintenance of stent length2
Median length change was 0 mm, predeployed to final implant
100% delivery to target lesion with no device dislodgement2,‡
100% stent retention2,‡
100% deployment at the target site2,‡
234 devices delivered
50% bilateral treatment
42% kissing stents
32% TASC II C & D including occlusions
18% contralateral deliveries
Predilatation not required
94.5%
1-year primary patency1
91.2%
freedom from target lesion revascularization (fTLR) at 3 years1
89.5%
primary patency per lesion through 5 years3
Animation - GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Kissing stents conformability
Related to this product
* Across indication inclusivity and configuration breadth/capability of balloon expandable covered stents.
† Complex defined as TASC II classification C & D lesions.
‡ Procedural outcomes based on usage of legacy GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXA catalogue numbers).
- 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.
- 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.
- 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. Journal of Endovascular Therapy. In press.
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed October 18, 2024. https://eifu.goremedical.com/
- LIFESTREAM® Balloon Expandable Vascular Covered Stent [Instructions for Use]. Tempe, AZ: Bard Peripheral Vascular, Inc; 2019. BAW1345700 Rev. 5 06/19
- iCast covered stent system [Instructions for Use]. Merrimack, NH: Atrium Medical Corporation; 2023. AW009603-EN Rev 11.
- Advanta V12 Balloon Expandable Covered Stent [Instructions for Use]. Merrimack, NH; Getinge AB. https://www.getinge.com/int/products/advanta-v12-balloon-expandable-covered-stent
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 U.S.: 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.
§