FRED™
Indications, Safety, and Warnings

See Instructions for Use for a complete list of warnings, precautions, and contraindications

  • MR Conditional

     

    The FRED (Flow Re-direction Endoluminal Device) and LVIS (Low-profile Visualized Intraluminal Support Device) are MR Conditional. Non-clinical testing demonstrated that these devices are MR Conditional. A patient with this device can be scanned safely, immediately after placement 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 (extrapolated) or less

    - 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)

    - Normal Operating Mode of operation for the MR system

     

    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

    1. 1

      Test Report TR14-160on file at MicroVention, Inc.