Medtronic INTPDFNNLA MRI Technical Manual
• INTPDVL42A
• INTPDVL42F
• INTPDVL48A
• INTPDVL48F
• INTPD-V4-42A
• INTPD-V4-48A
Intrepid™ Transcatheter Mitral Valve Replacement System
CAUTION: Investigational device. Limited by Federal (or United States) law to
investigational use.
Exclusively for Clinical Investigations
See below or contact LifeLine Technical Support (+1 763 526 7890 [USA: 1 877 526 7890]) for
MRI safety information for the following bioprosthesis models:
Magnetic resonance imaging (MRI) safety information
Nonclinical testing has demonstrated that the bioprosthesis is MR Conditional. A patient with
this device can be scanned safely in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T or 3 T
• Maximum spatial field gradient of 4000 gauss/cm (40.0 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of
2.0 W/kg (Normal Operating Mode) at 1.5 T and 3 T
Based on the nonclinical testing, under the scan conditions defined above, the bioprosthesis is
expected to produce a maximum temperature rise of less than 3.7ºC after 15 minutes of
continuous scanning.
Caution: The radio frequency (RF) heating behavior does not scale with static field strength.
Devices that do not exhibit detectable heating at one field strength may exhibit high values of
localized heating at another field strength.
In nonclinical testing, the maximum image artifact caused by the device extends approximately
0.7 cm from the bioprosthesis when imaged with a gradient-echo pulse sequence in a 3 T MRI
system.
© 2020 Medtronic
*M975931A001*
M975931A001 Rev. AA
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