14
Required Equipment
Ancillary Equipment
balloon(s) for possible
ballooning of iliac limb to aortic
body junction;
-
Non-compliant balloons for
treatment of and equivalent
size to the distal iliac diameter;
-
Compliant and non-compliant
balloons for treatment of and
equivalent size to the aortic
diameter.
•
Range of sizes of commercial
stents
•
Embolization devices such as
coils
9.4. MRI Information
MR Conditional
MR Conditional
The Ovation Abdominal Stent Graft System was determined to be MR Conditional.
Non-clinical testing demonstrated that the Ovation Abdominal Stent Graft System is
MR Conditional. 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, the Ovation Abdominal Stent Graft System 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-Tesla
3-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
+1.9 ˚C
+2.3 ˚C
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 the Ovation Abdominal Stent Graft System.
Therefore, optimization of MR imaging parameters to compensate for the presence
of this device may be necessary.
