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UroLift™ 2 ATC Advanced Tissue Control System
ItemUL2ATC-C
UOM BX
Packaging 2 / BX

Product review summary

Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions.

Item Description

UroLift™ 2 ATC Advanced Tissue Control System

The UroLift™ 2 ATC Advanced Tissue Control System (UroLift™ 2 ATC System) introduces tissue control wings to the UroLift™ 2 System. Innovating on the #1 chosen minimally invasive treatment for benign prostatic hyperplasia (BPH) in the U.S.,1 the UroLift™ 2 ATC System is designed to make it easier for urologists to treat more patients with confidence.

With the UroLift™ 2 ATC System, urologists can customize treatment to a patient’s unique anatomy. The UroLift™ 2 ATC System offers enhanced control of tissue using tissue control wings that hold tissue during manipulation while aiding in visualization. The UroLift™ 2 ATC System also features laser-etched needle location markers to help with targeting and delivery of implants.

The UroLift™ 2 ATC System consists of the same Delivery Handle as the UroLift™ 2 System, the ATC Implant Cartridge (with tissue control wings and gold knob), and the classic UroLift™ Implant. Each UroLift™ 2 ATC Implant Cartridge comes pre-loaded with the components of one UroLift™ Implant. Typically, one Delivery Handle is needed per procedure for up to eight implants.

The UroLift™ 2 ATC System is sold as UL2ATC-C in a package consisting of: two UroLift™ 2 ATC Implant Cartridges.

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

MAC02949-01 Rev A