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Preserve Flow. 

Advance Care.

 

The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is the only FDA approved, off-the-shelf iliac branch solution and is designed to preserve blood flow to external and internal iliac arteries.  


    See the results: 

    IDE Study Outcomes. Five-year follow-up* 

     

    100% patency

    — external iliac artery

    95.1% patency

    — Internal iliac artery

    98.3%

    freedom from CIAA enlargement


    95.2%

    freedom from IBE-related reintervention

    reliability-red

    0%

    buttock claudication
    new onset erectile dysfunction

    accuracy-red

    ZERO

    type I/III endoleaks migrations

    * U.S. IDE Clinical Trial. Sixty-three subjects with device implanted in initial cohort. Thirty-six patients have completed five-year follow-up. 
    † Core Lab reported assessment for patency, endoleak, migration and CIAA enlargement (> 5mm). Denominator is number of subjects evaluated for primary effectiveness endpoint result with an evaluable result.
    ‡ On the side treated with the IBE.

    Why preservation matters

    If someone were to ask me why iliac preservation is necessary, there’s multiple reasons why that’s the case...the first and most important thing, it’s for the patients. Secondly, as Vascular Surgeons our whole job is about fixing and preserving blood vessels so if we can avoid sacrificing an important blood vessel, we should do that.

    - Darren Schneider, M.D.

    The recommended treatment1,2 to sustain quality of life 

     

      The GORE® EXCLUDER® Iliac Branch Endoprosthesis can be used with the GORE® EXCLUDER® AAA Endoprosthesis or GORE® EXCLUDER® Conformable AAA Endoprosthesis to create an off-the-shelf solution you can count on. 

      Related to this product


      1. Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. Journal of Vascular Surgery 2018;67(1):2-77.e2.
      2. Moll FL, Powell JT, Fraedrich G, et al. European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European Society for Vascular Surgery. European Journal of Vascular & Endovascular Surgery 2011;41(Supplement 1):S1-S58.

       


      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 U.S.: Iliac Branch and Internal Iliac Components. The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is intended to be used with the GORE® EXCLUDER® AAA Endoprosthesis or the GORE® EXCLUDER® Conformable AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: adequate iliac/ femoral access; minimum common iliac diameter of 17 mm at the proximal implantation zone of the IBE; external Iliac artery treatment diameter range of 6.5–25 mm and seal zone length of at least 10 mm; internal iliac artery treatment diameter range of 6.5–13.5 mm and seal zone length of at least 10 mm; adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components. GORE® EXCLUDER® AAA Endoprosthesis Components used in conjunction with GORE® EXCLUDER® Iliac Branch Endoprosthesis. Trunk-Ipsilateral Leg Component. The Trunk-Ipsilateral Leg is intended to provide proximal seal and fixation for the endovascular repair of the aneurysm. For more information on the Trunk-Ipsilateral Leg Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis or the GORE® EXCLUDER® Conformable Endoprosthesis Instructions for Use. Contralateral Leg Endoprosthesis Component. The Contralateral Leg Endoprosthesis is intended to bridge the GORE® EXCLUDER® Device Trunk-Ipsilateral Component to the GORE® EXCLUDER® Iliac Branch Endoprosthesis following deployment of the GORE® EXCLUDER® Iliac Branch Endoprosthesis. Additionally, the Contralateral Leg Endoprosthesis is intended to be used for distal extension of the Iliac Branch Component in the external iliac artery. The Iliac Branch Component can treat external iliac artery diameters up to 13.5 mm. This ability to extend the Iliac Branch Component distally with any Contralateral Leg Endoprosthesis expands the external iliac artery treatment range up to 25 mm. For more information on the Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis Instructions for Use. Aortic Extender and Iliac Extender Components. The Aortic and Iliac Extender Components can be used after deployment of the GORE® EXCLUDER® Iliac Branch and GORE® EXCLUDER® AAA Endoprostheses. These extensions are used when additional length and/or sealing for aneurysmal exclusion is desired. 

      CONTRAINDICATIONS: The GORE® EXCLUDER® Iliac Branch Endoprosthesis is contraindicated in: patients with known sensitivities or allergies to the device materials. All components of the GORE® EXCLUDER® Iliac Branch Endoprosthesis and the GORE® EXCLUDER® AAA Endoprosthesis contain ePTFE, FEP, nitinol (nickel-titanium alloy) and gold; patients with a systemic infection who may be at increased risk of endovascular graft infection.