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FDA NEWS RELEASE

For Immediate Release: Sept. 13, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

New medical device treats urinary symptoms related to enlarged prostate

The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.

The prostate is a walnut-sized gland, in men, that sits below the bladder. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia (BPH). When the prostate is enlarged it can restrict or block urine flow. The UroLift system relieves the urine flow by pulling back the prostate tissue that is pressing on the urethra.
  
More than half of all men in their sixties and as many as 90 percent of men in their seventies and eighties have some symptoms of BPH such as more frequent urination with hesitant, interrupted, or weak stream and urgency and leaking. Severe BPH can lead to serious problems over time, such as strain on the bladder, urinary tract infections, bladder or kidney damage, bladder stones, and the inability to control urine (incontinence). Current treatment options to relieve symptoms associated with BPH include drug therapy or surgical procedures including removal of the enlarged part of the prostate.

“The UroLift provides a less invasive alternative to treating BPH than surgery,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This device also may offer relief to men who cannot tolerate available drug therapies.”  

The FDA’s review of the UroLift system included data from two clinical studies of men with BPH implanted with two or more UroLift sutures. The first study included 64 men between the ages of 53 and 83, and the second study included 210 men between the ages of 49 and 86. Both studies showed that physicians successfully inserted UroLift in 98 percent of participants.

The studies also measured participant urine flow and ability to empty the bladder, and throughout the study period, found a 30 percent increase in urine flow and a steady amount of residual urine in the bladder. Study participants answered validated questionnaires about their BPH-related symptoms and quality of life, reporting a decrease in symptoms and an increase in quality of life in the two years following treatment.

Minor adverse events reported included pain or burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of the bladder, and decreased urine flow. Investigators did not report any serious device-related adverse events.

The FDA reviewed the UroLift system through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

The UroLift System is manufactured by NeoTract Inc. of Pleasanton, Calf.

For more information:

FDA: Medical Devices

FDA: Evaluation of Automatic Class III Designation (De Novo) Summaries

NIH: Prostate Enlargement: Benign Prostatic Hyperplasia

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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