GORE® EXCLUDER® Iliac Branch Endoprosthesis
This device is labeled as MR Conditional. This means that the device has a demonstrated safety in a specified MRI environment with the defined conditions of use listed. The information on this page provides only a summary of MR conditions and is intended as a reference for EMEA only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of March 2025. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
| MR status | MR Conditional |
|---|---|
| Static magnetic field strengths | 1.5 tesla or 3.0 tesla |
| Maximum spatial gradient | 3000 gauss/cm (30 T/m) |
| Max whole-body-averaged specific absorption rate (SAR) | 4 W/kg (first level controlled operating mode) |
| Scan duration | 15 minutes of continuous scanning |
| Image artifact (3 tesla, gradient echo pulse sequence) | 5 mm from the device The artifact does not obscure the device lumen |
| Time (post-implant) to safely scan | Immediately after placement |
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 EUROPE: Iliac Branch and Internal Iliac Components. 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; Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Components; The Trunk-Ipsilateral Leg and Contralateral Leg Endoprostheses are intended to provide proximal seal and fixation to the GORE® EXCLUDER® Iliac Branch Endoprosthesis following deployment of the GORE® EXCLUDER® Iliac Branch Endoprosthesis. For more information on the Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Conformable Endoprosthesis Instructions For Use.
Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components. The Aortic and Iliac Extender Endoprostheses can be used after deployment of the GORE® EXCLUDER® Iliac Branch and AAA Endoprostheses. These extensions are used when additional length and / or sealing for aneurysmal exclusion is desired. For more information on Aortic Extender and Iliac Extender indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Conformable Endoprosthesis Instructions For Use.
CONTRAINDICATIONS: The GORE® EXCLUDER® Iliac Branch Endoprosthesis is contraindicated in: patients with known sensitivities or allergies to the device material and patients with a systemic infection who may be at increased risk of endovascular graft infection.