FRED™ Indications, Safety, and Warnings

MRI Safety Information

MR Conditional

FRED System
Non-clinical testing has demonstrated that the FRED System is MR Conditional. A
patient with this device can be safely scanned in an MR system under the following
conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only
- Maximum spatial gradient magnetic field of 2,500-gauss/cm (25-T/m)
-Maximum MR system reported, whole body averaged specific absorption rate
(SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

Under the scan conditions defined, the FRED System is expected to produce a
maximum temperature rise of 2.8 ºC at 1.5-Tesla or 3.6 ºC at 3-Tesla after 15-
minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the device extends approximately 4-mm from the FRED System when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

Terumo Neuro recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation or equivalent organization. A FRED System patient implant card is included in the package, which should be completed and provided to the patient.

MRI-Related Heating

In non-clinical testing¹, the FRED™ (Flow Re-direction Endoluminal Device) and LVIS™ (Low-profile Visualized Intraluminal Support Device) produced the following temperature rises during MRI performed for 15-min of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:

MR system reported, whole body averaged SAR

1.5-Tesla
2.9-W/kg                  

3-Tesla
2.9-W/kg

Calorimetry measured values, whole body averaged SAR

1.5-Tesla
2.1-W/kg                  

3-Tesla
2.7-W/kg

Highest temperature change

1.5-Tesla
2.8˚C               

3-Tesla
3.6˚C

Artifact Information

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the FRED™ or LVIS™ device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 4-mm relative to the size and shape of this implant. The lumen of this device can be visualized using the MRI techniques applied for the artifacts tests.

Pulse Sequence       T1-SE                 T1-SE                GRE                GRE 

Signal Void Size        462-mm2           41-mm2             743-mm2         72-mm2

Plane Orientation       Parallel             Perpendicular     Parallel            Perpendicular