Female doctor

GORE® VIABAHN® Device family

Join the next generation of care in the treatment of aortoiliac occlusive disease

The latest generation of covered stent grafts

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft)

Decide with data 

The Gore VBX FLEX Clinical Study 3-year follow-up found the VBX Stent Graft to be a robust and durable treatment option for AIOD.1  Now, sustained patient benefit and durability are demonstrated through 5 years.

Investigator Insights

Andrew Holden, M.D. discusses the background, outcomes and implications of this 5-year long-term data.

Physician-initiated 5-year VBX Stent Graft follow-up
 

Objective and methodology2
 

  • This physician-initiated study enrolled 59 patients from 3 participating centers that were representative of the VBX FLEX Study 3-year follow-up cohort. Twenty-eight patients completed the 5-year follow-up.
  • The primary durability endpoint was long-term primary patency.

 

DURABLE CLINICAL OUTCOMES THROUGH 5 YEARS2:

 

SUSTAINED PATIENT BENEFIT THROUGH 5 YEARS2:

sustained patient benefit through 5 years graphic

 

The case for long-term durable clinical outcomes:

Case study 1: Treating severe aortoiliac occlusive disease (AIOD) at the aortic bifurcation
Case study 2: Restoring flow to a patient with stenosis at the aortoiliac bifurcation
Case study 3: Restoring flow in a patient with severe claudication and focal iliac calcification

Visit the VBX Stent Graft product page. >

 

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface†

Proven patency with unmatched versatility‡

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Visit the VIABAHN® Device product page. >

VIABAHN® Device outcomes in iliac occlusive disease

Prospective, multicenter, single-arm study

53 patients (61 limbs) with iliac artery occlusion or stenosis (Mean lesion length: 6.9 cm; 48% of limbs in the external iliac artery)

91% primary patency at one year. 95% secondary patency at one year

* (P < .001) Statistically significant change from pre-procedure.
† As used by Gore, Heparin Bioactive Surface refers to Gore's proprietary CBAS® Heparin Surface. 
‡ Across indication inclusivity, and configuration breadth/capability of balloon expandable covered stents.

  1. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736.
  2. Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliac occlusive disease treated with the Viabahn VBX Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy. In press.
  3. Lammer J, Dake MD, Bleyn J, et al. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent graft. Radiology 2000;217(1):95-104.

 

eIFU Symbol

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.
CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the market where this product is available. RXOnly

22703753-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.