FDA Approves Implant for Enlarged Prostate Symptoms
Treatment increases urine flow (September 13)
The FDA has authorized the marketing of the UroLift system (NeoTract Inc.), the first permanent implant to relieve low or blocked urine flow in men 50 years of age and older with an enlarged prostate, 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.
The FDA’s review 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% of participants.
The studies also measured participants’ urine flow and their ability to empty the bladder, and found a 30% increase in urine flow.
Study participants reported a decrease in symptoms and an increase in quality of life in the 2 years following treatment.
Source: FDA; September 13, 2013.