The trusted choice for iliac preservation

The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is the first FDA approved, off-the-shelf iliac branch solution and is designed to preserve blood flow to external and internal iliac arteries. The GORE® EXCLUDER® IBE is the most-studieda iliac branch device, leveraging over 25 years of GORE EXCLUDER Family design expertise.

 a Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.

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    Trusted choice for tortuosity

    Proven kink resistance1-3

    The flexibility and conformability needed in challenging iliac anatomies

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    Broadest treatment rangeb

    Designed for iliac arteries

    Broadest internal and external iliac diameter ranges and lowest profile device

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    Designed for ease-of-use

    Two-stage deployment

    Ease of snaring and stability in delivery; Pre-cannulated internal iliac gate

    b Broadest treatment range for iliac preservation determined by cumulative comparison of EIA and IIA seal diameter, EIA seal length, CIA diameter and length, CIA bifurcation diameter, device profile, bilateral treatment, and renal-to-hypogastric length. COOK® ZENITH® Iliac Branch (ZBIS) may have broader range for individual factors.

    Preservation Matters – A.L.W.A.Y.S.

    Iliac artery preservation is the recommended treatment4,5 to sustain quality of life. A.L.W.A.Y.S. provides a simple way to remember key considerations for your decision.

    Learn more

      Durable outcomes. Proven performance.

      IDE Study outcomes, five-year follow-up6 

      100%

      external iliac artery patencyb

      95.1%

      internal iliac artery patencyb

      96.8%

      freedom from CIAA enlargementb,c

      95.2%

      freedom from IBE-related reintervention

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      0%

      buttock claudicationc
      new onset erectile dysfunction

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      ZERO

      type I/III endoleaksb
      migrationsb

      b 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.

      c On the side treated with the IBE.

      Related to this product

      1. Della Schiava N, Arsicot M, Boudjelit T, Feugier P, Lermusiaux P, Million A. Conformability of GORE Excluder Iliac Branch Endoprosthesis and COOK Zenith Bifurcated Iliac Side Branched Iliac Stent Grafts. Annals of Vascular Surgery 2016;36:139-144.
      2. Simmering JA, van Helvert M, van Herwaarden JA, Slump CH, Geelkerken RH, Reijnen MMPJ. Differences in cardiac-pulsatility-induced displacement and geometry changes between the Cook ZBIS and Gore IBE: postoperative comparison using ECG-gated CTA scans. Diagnostics 2023;13(3):496.
      3. Simonte G, Parlani G, Farchioni L, et al. Lesson learned with the use of iliac branch devices: single centre 10 year experience in 157 consecutive procedures. European Journal of Vascular & Endovascular Surgery 2017;54(1):95-103.
      4. 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.
      5. 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.
      6. Schneider DB, Matsumura JS, Lee JT, Peterson BG, Chaer RA, Oderich GS. Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device. Journal of Vascular Surgery 2023;77(1):122-128.
         
      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. 

      INDICATIONS FOR USE IN CANADA: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is intended 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.

      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. 

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