NeoTract obtains FDA de novo clearance for prostate implant

15 September 2013 (Last Updated September 15th, 2013 18:30)

US-based NeoTract has received the US Food and Drug Administration (FDA) authorisation to market UroLift system, which is the first permanent implant designed to relieve low or blocked urine flow in men age 50 and older with enlarged prostates.

US-based NeoTract has received the US Food and Drug Administration (FDA) authorisation to market UroLift system, which is the first permanent implant designed to relieve low or blocked urine flow in men age 50 and older with enlarged prostates.

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, opening the urethra while leaving the prostate intact.

The FDA's Center for Devices and Radiological Health, office of device evaluation director Christy Foreman said 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 said.

"This device also may offer relief to men who cannot tolerate available drug therapies."

Under the process of approval, the FDA has reviewed the data from two clinical studies of men with BPH implanted with two or more UroLift sutures.

While the first study included 64 men aged 53-83, the second study included 210 men aged 49-86.

There was a 30% increase in urine flow and a steady amount of residual urine in the bladder during the study period. The study participants also reported the increased ability to empty the bladder and a decrease in symptoms.

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.

However, the study investigators did not report any serious device-related adverse events.

The FDA reviewed the UroLift system through its de novo classification process, an alternate regulatory pathway to classify certain new devices that had automatically been placed in class III due to lack of a predicate.