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 PROPATEN 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® Endoprosthesis 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, PROPATEN Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface. 

  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 EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:

  • de novo or restenotic lesions in the iliac arteries
  • de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
  • popliteal artery aneurysms and isolated visceral artery aneurysms
  • 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:

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