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.

Endovascular management of lesions at points of flexion that require stenting is challenging: 

  • Stent grafts must be able to conform to the anatomy to provide thorough range of motion and be durable to resist fractures.
  • Flexion points in the circuit outside of the elbow are often underappreciated.
    • Positional studies highlight points of flexion outside of the elbow.1 
The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*,† is engineered for long-term performance in areas of flexion:
Proven patency when placed across the elbow

72%

target lesion six-month primary patency.2

67%

circuit six-month primary patency.2

Demonstrated durability

83%

access secondary patency and zero device fractures at two years when placed across the elbow.3

The VIABAHN® Device has a reported fracture rate of

.0032% across all uses

(Data on file 2022; W. L. Gore & Associates, Inc.; Flagstaff, AZ.)

The [VIABAHN® Device] has the flexibility, durability and the indication to successfully treat lesions across the antecubital fossa. In my experience, the device does not compress or kink when the extremity is flexed as compared with other stent grafts… 

William DaVanzo, M.D.

* 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.

1. Webb M.  Flow disturbances of upper arm graft outflow uncovered by positional studies. Endovascular Today 2014;13(6)Supplement:31-33.

2. Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery 2016;64(5):1400-1410.e1. http://www.sciencedirect.com/science/article/pii/S0741521416301756

3. W. L. Gore & Associates, Inc. GORE® VIABAHN® Endoprosthesis versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients. (GORE REVISE Study, AVR 06-01). Flagstaff, AZ: W. L. Gore & Associates, Inc; 2012. [IDE Final Clinical Study Report]. G070069.

4. Haruguchi H, Fukasawa M, Ikeda K, et al. Treatment with a self-expanding endoprosthesis in patients with stenosis or occlusion at the arteriovenous graft: 6-month outcomes of a post-marketing surveillance study. Journal of Vascular Access. In press.

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.

24PL1077-EN01