FAQs

The FDA-cleared UroLift^® System is the only treatment that uses the Prostatic Urethral Lift (PUL) procedure. The UroLift^® System treatment is a proven, minimally invasive approach for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) that typically does not require ongoing medications and avoids major surgery. The UroLift^® System’s implants, designed to be permanent, delivered during a minimally invasive outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.

As with any medical procedure, individual results may vary. Most common side effects are mild to moderate and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge. Most symptoms resolve within two to four weeks after the procedure.

The UroLift^® System consists of a delivery device and small implants, designed to be permanent.

• The UroLift^® Delivery Device is placed through the obstructed urethra.
• Small UroLift^® Implants are placed to lift or hold the enlarged prostate tissue out of the way like a curtain-tie. The implants are delivered through a small needle that comes out of the delivery device and into the prostate.
• The UroLift^® Delivery Device is removed, leaving an open urethra that provides symptom relief.

The UroLift^® System does not keep someone from having future BPH treatments if they are necessary.

The implants are intended to be permanent. The implant is made up of standard surgical implantable materials: a nitinol capsular tab, a stainless steel urethral tab, and polyethylene suture that holds the two tabs together. The urethral implant can be removed if needed. The suture can be cut and the urethral end piece can be retrieved with a standard grasper. The capsular tab will remain in place inside the body.

The UroLift^® Delivery Device is a single-use, sterile medical device that contains one UroLift^® Implant. The number of implants used in a procedure is determined by the treating physician and will vary by patient. The Delivery Device is inserted transurethrally through a rigid sheath under cystoscopic visualisation in order to reach the targeted area of obstruction.

The implants are designed to be permanent. The implant is made up of standard surgical implantable materials: a nitinol capsular tab, a stainless steel urethral tab, and a polyethylene terephthalate suture that holds the two tabs together. The urethral tab can be removed if needed. The suture can be cut and the urethral tab can be retrieved with a standard grasper. The capsular tab and part of the suture will remain in place inside your body.

The implant is made up of standard surgical implantable materials: a nitinol tab, a stainless-steel tab and a polyester suture that holds the two tabs together. The urethral implant can be removed if needed.

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 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 implant deploying device should not be used within the MR environment.

Patient implant cards are provided to inform the patient that the UroLift^® System implant is MR Conditional and can safely be scanned only under specific MR conditions.

The implants are not expected to interfere with a DRE. The implants are placed on the anterior (front) side of the prostate, and a DRE is conducted on the posterior (back) side of the prostate.

The UroLift^® System treatment has been found to be a safe and effective treatment for symptoms related to BPH. Its risk profile is better than reported for most traditional surgical options, and patients report symptom relief better than reported with medications.¹ In the large, pivotal study on the UroLift^® System, there were no instances of new, sustained erectile dysfunction or ejaculatory dysfunction*¹

We have over 22 select sponsored publications and over 140 peer-reviewed publications demonstrating the UroLift^® System is safe and effective. Improvement in urinary symptoms, as seen through reduction in IPSS (International Prostate Symptom Score), has been consistent across the various studies, showing rapid relief in as early as two weeks and sustained effect to five years.²

In our clinical studies, the most common side effects are temporary and can include discomfort when urinating, urgency, inability to control the urge, pelvic pain, and some blood in the urine. Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Most symptoms resolved within two to four weeks after the procedure.¹