NeoTract has received an approval from the US Food and Drug Administration (FDA) to market its UroLift system, designed to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate (benign prostatic hyperplasia).
The UroLift system pulls back the prostate tissue that is pressing on the urethra to relieve the urine flow in benign prostatic hyperplasia (BIH) patients.
FDA Center for Devices and Radiological Health Office of Device Evaluation director Christy Foreman noted the UroLift provides a less invasive alternative to treating BPH than surgery.
"This device also may offer relief to men who cannot tolerate available drug therapies," Foreman added.
The FDA’s review of the UroLift system is based on the data from two clinical studies of men with BPH implanted with two or more UroLift sutures.
The FDA reviewed the UroLift system through its de novo classification process, which applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices.