Medtronic HTPVDS0025 Product Information
Harmony™ Transcatheter Pulmonary Valve and Delivery System
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational
use.
Investigational Device/Instrument de recherche. To be used by Qualified Investigators
Only/Réservé uniquement à l'usage de chercheurs compétents.
See below or contact LifeLine Technical Support (+1 763 526 7890
[USA: 1 877 526 7890]) for MRI safety information for the following transcatheter
pulmonary valve (TPV) Models:
• NTPV0022
• HTPV254252
MRI safety information
Nonclinical testing and modeling have demonstrated that the TPV 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 or 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 4.0 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the TPV is expected to produce a maximum in
vivo temperature rise of less than 3.4°C after 15 minutes of continuous scanning.
In nonclinical testing, the image artifact caused by the device extends approximately
3 mm from the TPV when imaged with a spin echo pulse sequence and 5 mm when
imaged with a gradient echo pulse sequence and a 3.0 T MRI system. The lumen of the
device was clear for the spin echo images and only partially obscured for the gradient
echo images.
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.
*M967120A001*
© 2019 Medtronic
M967120A001 Rev. 1D
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