GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is not authorized for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts in Canada.

A case study using the VIABAHN® Device

Challenge

  • 72-year-old male with thrombosed left arm arteriovenous (AV) graft 
  • Graft was initially placed eight years ago followed by multiple interventions 
Angiogram

 

Image: Thrombosed left arm AV graft. 80% stenosis just past venous anastomosis. 

Images courtesy of Jason Burgess, M.D. Used with permission. 

Procedure 

  • A percutaneous thrombectomy was performed with the BOSTON SCIENTIFIC ANGIOJET Thrombectomy System 
  • The patient was found to have 80% stenosis just past the venous anastomosis 
  • Stenosis at the venous anastomosis was treated with balloon angioplasty with immediate recoil of stenosis 
  • A VIABAHN® Device, 7 mm x 5 cm, was then placed across the venous anastomosis 
angiogram

 

Image: Prior to the placement of a VIABAHN® Device, balloon angioplasty was performed to predilate the lesion at the venous anastomosis of the graft. 

Images courtesy of Jason Burgess, M.D. Used with permission. 

Result 

  • Excellent angiographic result 
  • Thrill restored to the graft 
Angiogram

 

Image: Post placement of 7 mm x 5 cm VIABAHN® Device 

Images courtesy of Jason Burgess, M.D. Used with permission. 

Case takeaways

The VIABAHN® Device successfully treated a graft outflow lesion that had failed balloon angioplasty. 
 
See additional clinical information

Related case studies

* As used by Gore, Heparin Bioactive Surface refers to Gore's proprietary CBAS® Heparin Surface. 

† Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions. 

BOSTON SCIENTIFIC and ANGIOJET are trademarks of Boston Scientific Corporation. 

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 (IFU) 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® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts.  

CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 

INDICATIONS FOR USE IN CANADA: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries. 

CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.

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