Magnetic Resonance Imaging (Mri) Safety - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

SECTION 1.5 MAGNETIC RESONANCE IMAGING (MRI) SAFETY
The Thoraflex™ Hybrid Device was determined to be Magnetic Resonance (MR)-conditional. Non-clinical
testing determined that grafts with radiopaque markers were MR conditional. A patient with this device can be
scanned safely, immediately after placement of the device 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.
MAGNETIC RESONANCE IMAGING (MRI) RELATED HEATING
In non-clinical testing, grafts with radiopaque markers produced the following temperature rises during Magnetic
Resonance Imaging performed for 15 minutes of scanning (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.
Artefact Information
MR image quality may be compromised if the area of interest is in the exact same area or close to the position
of the graft with radiopaque markers. Therefore, optimisation of MR imaging parameters to compensate for the
presence of this device may be necessary. The maximum artefact size (i.e. as seen on the gradient echo pulse
sequence) extends approximately 10mm relative to the size and shape of this implant.
Pulse Sequence
Signal Void Size
Plane Orientation
This information is based on information from the Food and Drug Administration and the American Society for Testing and Materials
(ASTM) International, Designation: F2503-08. Standard Practice for Marketing Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment.
8
T1-SE T1-SE
15, 818 mm 1, 424 mm
2
Parallel Perpendicular
GRE
19, 077 mm
2
Parallel
1.5 Tesla 3 Tesla
2.9 W/kg 2.9 W/kg.
2.1 W/kg 2.7 W/kg.
+1.7°C +2.0°C.
GRE
2, 012 mm
2 2
Perpendicular