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 the U.S. only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of November 2022. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
GORE® EXCLUDER® Conformable AAA Endoprosthesis
|MR status||MR Conditional|
|Static magnetic field strengths||1.5 tesla or 3.0 tesla only|
|Maximum spatial gradient||3000 gauss/cm (30 T/m) or less|
|Max whole-body-averaged specific absorption rate (SAR)||2 W/kg (normal operating mode)|
|Scan duration||15 minutes of continuous scanning|
|Image artifact (3 tesla, gradient echo pulse sequence)||8 mm from the device
The artifact does not obscure the device lumen
|Time (post-implant) to safely scan||Immediately after placement|
INDICATIONS FOR USE: Trunk-Ipsilateral Leg Endoprosthesis and Contralateral Leg Endoprosthesis Components. The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: Adequate iliac/femoral access; Infrarenal aortic neck treatment diameter range of 16–32 mm and a minimum aortic neck length of 15 mm; Proximal aortic neck angulation ≤ 60°; Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm. Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components. The Aortic and Iliac Extender Endoprostheses are intended to be used after deployment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired.
CONTRAINDICATIONS: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the device materials; Patients with a systemic infection who may be at increased risk of endovascular graft infection. 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