LVIS™ & LVIS™ Jr Indications, Safety, and Warnings

MRI Safety Information

MR Conditional

The LVIS™ and LVIS™ Jr. device has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503.

Non-clinical testing demonstrated that the LVIS device is MR conditional. A patient 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 720 Gauss/cm or less

Whole body averaged specific absorption rate of 2 W/kg in the normal operating mode for a maximum scan time of 15 minutes

MRI-Related Heating

In non-clinical testing, the 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:

1.5-Tesla3-Tesla

MR system reported, whole body averaged SAR 2.9-W/kg 2.9-W/kg

Calorimetry measured values, whole body averaged SAR 2.1-W/kg 2.7-W/kg

Highest temperature change +2.2°C +2.6°C

These temperature changes will not pose a hazard to a human subject under the conditions indicated above.

Image 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 implant. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 5-mm relative to the size and shape of this implant.

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

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