Medgadget previously reported on the initiation of US clinical trials for the UroLift System, a device being developed by NeoTract, Inc. a Pleasanton, California-based company. The implanted suture-based device to help men with with lower urinary symptoms of benign prostatic hyperplasia (BPH), or simply enlargement of the prostate, has now received FDA approval.
BPH is a common condition afflicting more than 500 million aging men worldwide. Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. Medication is often the first line therapy but relief can be inadequate and temporary. The UroLift System is designed to open the urethra directly without applying incisions, surgical resection or thermal injury to the prostate. Obstructive prostate lobes are transurethrally pushed aside and small permanent UroLift implants hold the lobes in the retracted position, thus opening the urethra while leaving the prostate intact.
“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, in a statement. “This device also may offer relief to men who cannot tolerate available drug therapies.”