VBX Product Image

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Trusted performance. Unmatched versatility.*

Proven procedural and clinical success†

 

restoration of lumen diameter1

X-ray image before

Before

X-ray image after

After

≤ 30% residual stenosis due to high radial strength, even in highly calcified and non-compliant lesions.

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.

 

maintenance of stent length1

Median length change was 0 mm, predeployed to final implant

Diagram of the VBX

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

Text reads: 89.5%

Primary patency per lesion

Text reads: 96.1%

Primary assisted patency per lesion

Text reads: 89.1%

fTLR per subject

 

Additional patient benefits versus baseline*,2

Icon showing plus comma fifteen

Improvement in mean resting ABI (from .76 to .95) [P < .001]‡

Icon showing three times

Improvement in median WIQ measures

Icon showing hundred per cent

of evaluated (n = 28) patients improved ≥ 1 Rutherford category from baseline§

 

3-year outcomes

Icon showing 91.2 percent

Freedom from target lesion revascularization (fTLR)3

Icon showing plus comma seventeen

Improvement in mean resting ankle-brachial index (ABI) (P < .001, .93 mean ABI)‡,3

Icon showing 92 percent

of patients improved ≥ 1 Rutherford category versus baseline3

 

1-year outcomes

Icon showing 94.5 percent

Primary patency3

Icon showing 96.1 percent

Primary patency in TASC C&D lesions at 1 year3

Icon showing 99.5 percent

Secondary patency3

* Across indications and configurations of covered stents.

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

‡ (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.

  1. 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
  2. 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
  3. 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
     

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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

24PL2171-EN01

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