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 conditions1:
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.1
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).
Source information
1. UroLift System - Instructions for use, data on file
Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence (Roehrborn, J Urology 2013). Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Consult the Instructions for Use (IFU) for more information.
Contraindicated in men with current gross hematuria, urinary tract infection, urinary incontinence, urethral conditions that prevent device insertion, or a prostate volume greater than 100cc.
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