Idiomas disponibles
Idiomas disponibles
MRI Information
UVENTA™ Urethral Stent was established to be MR-conditional.
Non-clinical testing demonstrated that Uventa™ Urethral 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, UVENTA™ Urethral 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, and 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 of Uventa™ Urethral 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
Perpendicul
Parallel
ar
3-Tesla
2.9-W/kg
2.7-W/kg
+2.4°C
GRE
2
977-mm
Perpendicul
ar
2
