GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Clinical Data
Proven procedural and clinical success*
≤ 30% residual stenosis due to high radial strength, even in highly calcified and non-compliant lesions.
100%
restoration of lumen diameter1
The Gore VBX FLEX Clinical Study is a prospective, multicenter, single arm study of 134 patients with complex aortoiliac occlusive disease (32.1% TASC II C and D, 42.5% kissing stent).
In the study, 234 devices were delivered; 50% bilateral treatment, 18% contralateral deliveries and predilitation was not required.
100%
maintenance of stent length1
Median length change was 0 mm, predeployed to final implant
100%
stent delivery
- 100% delivery to target lesion with no device dislodgement1
- 100% stent retention1
- 100% deployment at the target site1
Proven patency and patient benefit*
5-year outcomes
VBX Stent Graft durability through 5 years assessed in a physician-initiated study that enrolled 59 patients from 3 participating centers representative of the VBX FLEX Study cohort.
Clinically proven results†,2
89.5%
Primary patency per lesion
96.1%
Primary assisted patency per lesion
89.1%
fTLR per subject
Additional patient benefits versus baseline†,2
+.15
Improvement in mean resting ABI (from .76 to .95) [P < .001]‡
3x
Improvement in mean WIQ measures
100%
Of evaluated (n = 28) patients improved ≥ 1 Rutherford category from baseline§
3-year outcomes
91.2%
Freedom from target lesion revascularization (fTLR)3
+.17
Improvement in mean resting ankle-brachial index (ABI) (P < .001, .93 mean ABI)‡,3
92%
Of patients improved ≥ 1 Rutherford category versus baseline3
1-year outcomes
94.5%
Primary patency3
96.1%
Primary patency in TASC C&D lesions at 1 year3
99.5%
Secondary patency3
Publications
Your resource for current publications and clinical data demonstrating the utility of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in practice.
* Based on prior clinical data. New evaluation of reduced profile delivery is underway.
† Across indications and configurations of covered stents.
‡ (P < .001) Statistically significant change from pre-procedure.
§ 59 subjects participated and 28 were available through the end of the study at 5-year follow-up.
- Bismuth J, Gray BH, Holden A, et al; 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. 2023;0(0). doi:10.1177/15266028231165723
- 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
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 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 followingII:
- 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.
II Not applicable to Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB catalogue numbers).