PTA failures of AV graft lesions

Not indicated for use in Canada.

Percutaneous transluminal angioplasty (PTA) has significant limitations when treating Arteriovenous (AV) access lesions1

  • Patency rates diminish with each successive angioplasty procedure.1,2
    • In the REVISE Clinical Study, patients undergoing PTA who had a previous intervention at the target lesion had lower primary patency at six months when compared with patients with no prior interventions at the target lesion (29.2% vs. 43.9%).1 
  • The 2019 KDOQI guidelines for vascular access specify a target goal of ≤ three interventions annually to maintain access.3
    • In support of achieving this goal, KDOQI recommends stent grafts in preference to angioplasty alone for recurrent clinically significant stenotic AV access lesions.
angiogram

Before

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

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

Read the full case study

angiogram

After

Post-placement of 7 mm x 5 cm GORE® VIABAHN® Endoprosthesis.

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

Read the full case study

The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*† has proven patency independent of the number of prior interventions1

Proven patency

  • Provided consistent patency independent of the number of times a lesion has previously been treated.1 
Six month target lesion chart

FEWER REINTERVENTIONS

  • Reduced the average number of reinterventions by 27% over two years within the circuit compared to PTA.4

Stent graft design provides unique benefits to the treatment of lesions refractory to PTA

  • Expanded PTFE (ePTFE) flow lumen covers and seals off diseased tissue.

 AV access maintenance challenges

  • The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface† has proven success in the most challenging AV access cases, including early PTA failures, lesions at points of flexion, and in thrombosed grafts.

Learn more.

Connect with a Gore Field Sales Associate

* 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. 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. Kanterman RY, Vesely TM, Pilgram TK, Guy BW, Windus DW, Picus D. Dialysis access grafts: anatomic location of venous stenosis and results of angioplasty. Radiology 1995;195(1):135-139.
  3. 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.
  4. 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.

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

eIFU Symbol

22797638-EN

Residents of some states have the right to opt-out of the “sharing” or “selling” of their personal information. Gore does not "sell" the personal information of website users. Gore may "share" the personal information of website users, as standard advertising practice meant to offer you a more personalized service.

If you want to opt-out from Gore “sharing” your personal information, click on Opt-Out of Sharing to turn off the targeting cookies that we share with our advertising partners in order to provide you with personalized information. Disabling sharing will stop the use of cookies to targeted advertising but you may still see generic Gore ads.

Please note that your exercising of the rights outlined will have no adverse effect on the price and quality of our goods or services.

Opt-Out of Sharing

You Have Successfully Opted Out of the Sharing of Your Personal Information

Please note that if you clear your cookies and then use another device or browser, etc. your opt-out status is not transferred to the new device or browser.