UroLift ATC® System
The UroLift® Advanced Tissue Control (ATC) System is a modification of the UroLift® System, a minimally invasive procedure to treat symptoms of an enlarged prostate secondary to benign prostatic hyperplasia (BPH). The primary enhancement is the addition of a wing component on the distal tip of the UroLift® Delivery Device. This design feature is intended to provide more tissue control, which may reduce procedural manipulations.
The UroLift ATC® System delivers the same proven UroLift® Implant through an enhanced delivery device tip. It features tissue control wings that hold tissue during manipulation, helping the urologist to mobilize obstructive tissue and pin it to the side to enhance visualization. The UroLift ATC® System also includes a needle location marker with laser-etched markings that can aid with targeting accuracy for predictable implant placement.
The UroLift ATC® System (UL400ATC) is sold packaged in one (1) box containing one (1) individually packaged UroLift ATC® System device.
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. 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.
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 ATC® 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 ATC® 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
MAC02527-05 Rev.A