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.

Patient presentation

  • 70-year-old male  
  • History of smoking, diabetes, hypertension, hyperlipidemia, coronary artery disease and myocardial infarction  
  • Rutherford category 3 

Clinical challenges

  • TASC II Type C lesion
  • Bilateral proximal common iliac lesion
  • Tortuous anatomy 
Achieving conformability and durable results in tortuous anatomy

Procedure 

Right: 10 mm x 39 mm
Left: 10 mm x 59 mm

VBX Stent Graft bilateral retrograde approach

VBX Stent Graft advances and conforms through tortuous anatomy and deploys in kissing stent configuration 

Achieving conformability and durable results in tortuous anatomy loading

Results

Widely patent arteries demonstrating VBX Stent Graft flexibility and radial strength in a highly tortuous vessel

VBX Stent Graft flexibility and patency shown in discharge ultrasound 

Widely patent arteries demonstrating VBX Stent Graft flexibility and radial strength in a highly tortuous vessel
VBX Stent Graft flexibility and patency shown in discharge ultrasound
  1. 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

Procedural outcomes based on usage of legacy GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXA catalogue numbers).

The outcomes and observations reported are based on individual case experience and the patients treated. The steps described here may not be complete, and are not intended to be a replacement for the Instructions for Use or the education, training and professional judgment of health care providers (HCP). HCPs remain solely responsible for making decisions about patient care and the use of medical technologies. 

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 

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.  

* Not applicable to Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXB catalogue numbers).

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