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MRI Safety and Compatibility
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Non-clinical testing has demonstrated that the AFX Endovascular AAA Stent Graft is MR Conditional.
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A patient with this implant can be scanned safely under the following conditions:
- Static magnetic field of 1.5 Tesla and 3.0 Tesla
- Spatial gradient field of 750 Gauss/cm or less
- Normal operating mode or a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 1.5 Tesla or 3.0 Tesla MR scanner.
In non-clinical testing, the Endologix Stent Graft produced the following temperature rises during MRI performed for 15 minutes in 1.5 Tesla (1.5 Tesla/64MHz, Magnetom, Software Numaris/4 version Syngo MR 2002B DHHS, Siemens Medical Solutions, Malvern, PA) and 3.0 Tesla (3.0 Tesla/128MHz, Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) MR Systems as follows:
|Highest Temperature Change (°C)||MRI Condition|
Therefore, the MRI-related heating experiments for the Endologix Stent Graft at 1.5 Tesla and 3.0 Tesla using a transmit/receive RF body coil at MR system reported whole body average specific absorption rates (SARs) of 2.9 W/kg (i.e., associated with a calorimetry value of 2.1 W/kg) and 3.0 W/kg (i.e., associated with a calorimetry value of 2.8 W/kg), respectively, indicated that the greatest amount of heating that occurred in association with these specific conditions was less than or equal to 3.6°C.
Image Artifact (1.5 and 3.0 Tesla MR Systems).
The image artifact extends approximately 10 – 20mm from the device, both inside and outside the device lumen when scanned in non-clinical testing using T1-weighted spin echo and gradient echo pulse sequences in a 3.0 Tesla MR system.
The artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal loss) that were moderate in size relative to the size and shape of these implants. The gradient echo pulse sequence produced larger artifacts than the T1 -weighted, spin echo pulse sequence for the Endologix Stent Graft. MR imaging quality may be compromised if the area of interest is in the same area or relatively close to the position of the stent graft. Therefore, it may be necessary to optimize MR imaging parameters to compensate for the presence of this implant.