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Arteriovenous (AV) access grafts that have thrombosed are often associated with worse outcomes than those that are stenosed1  

 

  • The 2019 KDOQI guidelines for vascular access specify a target goal of ≤ three interventions annually to maintain access2:
    • In support of achieving this goal, KDOQI recommends stent grafts in preference to angioplasty alone for recurrent thrombotic AV access lesions. 

 

There are a limited number of randomized trials to help guide evidence-based treatment decisions for patients with thrombosed grafts 

 

  • In the Gore REVISE Clinical Study, 43% of patients in the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* arm of the study enrolled with a thrombosed graft.
Before

Treatment of stenosis at the venous anastomosis of a synthetic graft.  

Image

Image courtesy of Thomas Ward, M.D. Used with permission. 

After

Post-placement of 8 mm x 7.5 cm VIABAHN® Device.

Image

Image courtesy of Thomas Ward, M.D. Used with permission. 

The VIABAHN® Device has proven success when treating thrombosed grafts1 

Proven patency
  • Exceeded KDOQI minimum guidelines for 3-month circuit primary patency for thrombotic patients (48%) whereas percutaneous transluminal angioplasty (PTA) did not (39%).1,2
  • Increased primary patency in thrombosed grafts of both the target lesion and the circuit by ~50% when compared to PTA at 6 months.1 
     
Fewer reinterventions
  • Lowered the mean number of interventions over 2 years by 40% in thrombosed grafts.3


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

  1. 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
  2. Lok CE, Huber TS, Lee T, et al; KDOQI Vascular Access Guideline Work Group. KDOQI Clinical Practice Guideline for Vascular Access: 2019 update. American Journal of Kidney Diseases 2020;75(4)Supplement 2:S1-S164.
  3. Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators.  Clinical and economic benefits of stent grafts in dysfunctional and thrombosed hemodialysis access graft circuits in the REVISE Randomized Trial. Journal of Vascular & Interventional Radiology 2019;30(2):203-211.e4. 
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.