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:
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.
Publication
Roehrborn, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Canadian Journal of Urology 2017.
Publication
European Association of Urology (EAU) guidelines on management of non-neurogenic male lower urinary tract symptoms (LUTS), including benign prostatic obstruction (BPO).
The UroLift System is a Medical Device, class: IIb. Notified Body : NSAI- CE 0050. Manufacturer: NeoTract Inc. Pleasanton -USA. . Please refer very carefully to the instructions for use for recommendations. Check the integrity of the packaging before use. Product reimbursed by health insurance organizations in certain situations: consult the terms and conditions on http://www.ameli.fr
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