Explore 6-month findings

Results from a prospective, real-world multicenter study of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surfacea,b from Japan show 94% secondary patency at 6 months.1 Watch the video to learn about the study details.
 

    Primary patency at 6 months1

    75%

    Target lesion

    67%

    Access circuit

    82%

    Target lesion primary patency with the VIABAHN® Device placed across the elbow

    Secondary patency at 6 months1

    94%

    Target lesion

    94%

    Access circuit

    Study patient and lesion characteristics

    N = 103 patients
    Female: 57% 
    Average age: 72 years 
    Average BMI (n = 76): 23 kg/m2
    Diabetic: 40%

    N = 105 lesions
    Average length (N = 93): 43 mm 
    Thrombosed grafts treated: 23%

    No statistical difference in target lesion primary patency with respect to1:

    • Crossing the elbow
    • Sex
    • Number of prior interventions
    • Diabetes
    • Age of circuit
    • Stent graft size and location
    • Stenosis vs occlusion
    • Elephant trunk placement (stent graft in the outflow vein lies without vessel wall apposition)
    VIABAHN Device placed across the elbow at 6 months

      Sustained performance through 1 year2

      Target lesion2
      Kaplan-Meier chart showing patency over 12 months post-treatment. Primary patency declines to 52.7% at 12 months, while secondary patency remains high at 91.5%.

      Kaplan-Meier estimates of target lesion primary and secondary patency.

      Access circuit2
      Kaplan-Meier chart showing patency over 12 months post-treatment. Primary patency declines to 35.9% at 12 months, while secondary patency remains high at 91.5%.

      Kaplan-Meier estimates of vascular access circuit primary and secondary patency.

      Durable performance at 2 years3

      The average number of days to reintervention after VIABAHN® Device placement was >200, no matter the location of the reintervention.3

      Medical illustration of the upper arm showing an arteriovenous access graft connecting an artery and vein. A white stent graft spans a narrowed section of the graft near the venous connection. Red hotspot markers identify key anatomical locations and device features. An inset image at upper left shows the graft placement within the elbow region from an external perspective.

      Choose an anatomical location to view the median time to the first reintervention when patients were followed for 2 years.³

      supportImage

      Showing of

      84%

      Secondary patency at the target lesion and access circuit through 2 years3

      31%

      Primary patency at the target lesion through 2 years3

      12%

      Primary patency of the access circuit through 2 years3

      Takeaways

      Two years after placement of the VIABAHN® Device, results demonstrated that the primary driver of access circuit failure shifted from the venous outflow to the intra-AV graft segment, which is characterized as the most frequent location for early restenosis.3

      a. As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
      b. Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions.

      1. 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. J Vasc Access. 2025;26(6):1829-1837. doi:10.1177/11297298241286249 
      2. Fukasawa M, Haruguchi H. A 1-year follow-up analysis of a post-market surveillance study of a self-expanding endoprosthesis for stenosis or occlusion at the arteriovenous access. J Vasc Access. 2026;27(1):169-175. doi:10.1177/11297298251330951 
      3. Suemitsu K, Miyamoto M, Murakami M. Two-year outcomes of stent graft placement for arteriovenous graft outflow stenosis: patency and patterns of reintervention from a prospective multicenter study. Presented at: Japan Endovascular Treatment Conference; February 6-8, 2026; Tokyo, Japan.
      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 US: 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.
       

      25PL1031-EN03 MAT-0849-1