FDA Approves UroLift System for Enlarged Prostate
The FDA has authorized the marketing of NeoTract Inc.'s UroLift system, a permanent implant to relieve low or blocked urine flow in men ages >50 years with an enlarged prostate.
The UroLift system is a minimally invasive device that pulls back the prostate tissue that is pressing on the urethra to improve urine flow. The device opens the urethra directly by retracting the obstructing prostatic lobes without applying incisions, surgical resection or thermal injury to the prostate.
The FDA's approval 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 aged 53–83 years, and the second study included 210 men aged 49–86 years.
Throughout the study period, there was a 30% increase in urine flow and a steady amount of residual urine in the bladder. Patients also reported 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.
For more information call (925) 401-0700 or visit NeoTract.com.