Mri Information - Taewoong Niti-S User Manual

MRI Information

Niti-S & comvi stent was determined to be MR-conditional.
Non-clinical testing demonstrated that the Niti-S & comvi stent is
MR Conditional according to ASTM F2503. A patient with this
device can be scanned safely, immediately after placement under
the following Conditions:
Static Magnetic Field
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or
less
MRI-Related Heating
In non-clinical testing, Niti-S & comvi 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
These temperature changes will not pose a hazard to a human
subject under the conditions indicated above.
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 Niti-S &
comvi 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.
Pulse
Sequence
Signal
Void Size
Plane
Orientation
MR Conditional
T1-SE
2
7,695-mm
Parallel
1.5-Tesla
2.9-W/kg
2.1-W/kg
+1.9°C
T1-SE GRE
2
676-mm 7,984-mm
Perpendi
Parallel
cular
3-Tesla
2.9-W/kg
2.7-W/kg
+2.4°C
GRE
2 2
977-mm
Perpendi
cular