UroLift™ 2 Procedure Kit
The UroLift™ 2 Procedure Kit (UL2-PK) contains one (1) individual, sterile, sealed package containing the UroLift™ 2 Delivery Handle and one (1) sterile, sealed package containing five (5) UroLift™ 2 Implant Cartridges, in a single, sealed tray.
The UroLift™ 2 System is the next-generation of the minimally invasive Prostatic Urethral Lift procedure to treat symptoms of an enlarged prostate secondary to benign prostatic hyperplasia (BPH). The UroLift™ 2 System delivers the UroLift™ Implant to provide an option for patients looking for an alternative to medications or major surgery. It is the only leading transurethral BPH treatment that does not require heating, cutting, or removal of prostate tissue.*
The UroLift™ 2 Procedure Kit contains the same Delivery Handle and individual Implant Cartridges. Each UroLift™ 2 Implant Cartridge comes pre-loaded with the components to form one UroLift™ Implant. Typically, one Delivery Handle is needed per procedure and each Delivery Handle may implant up to eight implants.
Data on file
1. U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
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 Urol 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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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.
INDICATIONS FOR USE
In the United States, the UroLift™ 2 ATC Advanced Tissue Control System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
CONTRAINDICATIONS
In the United States, the UroLift™ 2 ATC Advanced Tissue Control System should not be used if the patient has:
• Prostate volume of >100 cc
• A urinary tract infection
• Urethral conditions that may prevent insertion of delivery system into bladder
• Urinary incontinence due to incompetent sphincter
• Current gross hematuria
MAC02527-17 Rev A