CoreValve™ Evolut™ PRO System
CAUTION: Investigational device. Limited by Federal (or United States) law to
investigational use.
See below or contact LifeLine Technical Support (1 877 526 7890) for MRI safety
information for the following bioprosthesis models:
• TAV-MDT2-23-C
• TAV-MDT2-26-C
• TAV-MDT2-29-C
Note: The CoreValve™ Evolut™ PRO system was previously named the Medtronic
TAVR 2.0 system.
MRI safety information
Nonclinical testing and modeling have demonstrated that the bioprosthesis is MR
Conditional. A patient with this device can be safely scanned in an MR system meeting
the following conditions:
• Static magnetic field of 1.5 T and 3.0 T
• Maximum spatial field gradient of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR)
of 2.0 W/kg (Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the
bioprosthesis is expected to produce a maximum in vivo temperature rise of less than
4.0°C after 15 minutes of continuous scanning. Based on nonclinical data, the image
artifact caused by the device will extend no greater than 7 mm from the bioprosthesis
when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.
Scanning under the conditions defined above may be performed immediately after
implantation.
The presence of other implants or medical circumstances of the patient may require lower
limits on some or all of the above parameters.
*M058433T001*
© 2018 Medtronic
M058433T001 Rev. 1D
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