Non-clinical testing has demonstrated that the UroLift Implant is MR Conditional. A patient with this device can be safely scanned in an MR system immediately after placement meeting the following conditions:
Static magnetic field of 3.0 Tesla or less
Maximum spatial field gradient of 1,500 Gauss/cm (15 T/m) (extrapolated)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of continuous scanning (i.e., per pulse sequence) (First Level Controlled Operating Mode)
Under the scan conditions defined above, the UroLift Implant is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence)
In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the UroLift Implant when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.
The safety of the delivery system has not been evaluated in the MR environment, and therefore, the delivery system should not be used within the MR environment.
Patient implant cards are provided to inform the patient that the UroLift implant is MR Conditional and can safely be scanned only under specific MR conditions.
If you have any questions about MRI safety, please consult your doctor.
