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    MRI Information

    Will the Implants Interfere with Having an MRI?

    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:

    • 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.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.

    Source Information

    * Dr. Roehrborn is a paid consultant of Neotract | Teleflex

    1. UroLift System - Instructions for use, data on file

    INFORMATION FOR PHYSICIANS ABOUT THE UROLIFT® SYSTEM

    The UroLift System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100 cc in men 50 years or older. The UroLift implants are permanent and can be delivered during an outpatient procedure, relieving prostate obstruction without heating, cutting, destructing, or removing prostate tissue. The UroLift System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.1 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.*2-4 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.5 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift System) is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines.

    Contraindicated in men with a prostate volume greater than 100cc or a urinary tract infection.

    Warning: This device contains stainless steel and nitinol, an alloy of nickel and titanium. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.

    Individual results may vary. For full information, please consult the Instructions for Use (IFU)

    *No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.

    1. Rukstalis, Prostate Cancer and Prostatic Dis 2018
    2. Roehrborn, Can J Urol 2017
    3. AUA BPH Guidelines 2003, 2020
    4. McVary, J Sex Med 2016
    5. Roehrborn, J Urology 2013

     

    Teleflex, BPH Relief In Sight and UroLift are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. ©2023 Teleflex Incorporated. All rights reserved. Revised: 02/2023. MC-008657 LA EN

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    São Paulo/SP - CEP 04717-913