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 market where this product is available. RXOnly 

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

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 following: 

  • 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.

 

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis with Reduced Profile:

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). 

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. 

Product may not be available in all countries. Please check with your Gore representative for availability.
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