Mri Information - Taewoong Niti-S Nagi Stent Manual Del Usuario

MRI Information

The Niti-S Nagi™ Stent is MR conditional. Non-clinical testing demonstrated that the
Niti-S Nagi™ Stent is 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 or 3-Tesla, only
• Maximum spatial gradient magnetic field of 5,000-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 testing, the Niti-S Nagi™ Stent 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
Calorimetry measured values, whole body
averaged SAR
Highest temperature change
Scaled to whole body averaged SAR of 2.0-W/kg
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 Niti-S Nagi™ Stent. 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 10-mm relative to the size and shape of this implant. The lumen could
not be visualized using these pulse sequences.
Pulse
Sequence
Signal Void
Size
Plane
Orientation
MR Conditional
T1-SE T1-SE
702-mm2 317-mm2
Parallel Perpendicular
1.5-Tesla 3-Tesla
2.9-W/kg 2.9-W/kg
2.1-W/kg 2.7-W/kg
2.9°C
2.0°C
GRE GRE
883-mm2 482-mm2
Parallel Perpendicular
2.4°C
1.7°C