FDA Approves NeoTract’s Prostate Treatment Device

Pleasanton, Calif.-based NeoTract Inc.’s new UroLift system has been given the go-ahead from the U.S. Food and Drug Administration (FDA), which approved the device through its de novo classification process reserved for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

“FDA approval of the UroLift System marks a significant milestone for NeoTract and brings a truly minimally invasive treatment option to the millions of men suffering from BPH in the United States,” said Dave Amerson, president and CEO of NeoTract. “We have been very impressed with the thorough and efficient De Novo review process conducted by the FDA.”

According to the FDA, the system is the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.

The prostate is a walnut-sized gland, in men, that sits below the bladder. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia (BPH). When the prostate is enlarged it can restrict or block urine flow. The UroLift system is designed to relieve the urine flow by pulling back the prostate tissue that is pressing on the urethra. It is a minimally invasive approach. The implants are individually tailored during delivery to transprostatically reshape the prostate thus reducing urethral obstruction directly without incisions, surgical resection or thermal effects on the prostate, often in an outpatient setting which may require only local anesthesia.

More than half of all men in their sixties and as many as 90 percent of men in their seventies and eighties have some symptoms of BPH such as more frequent urination with hesitant, interrupted, or weak stream and urgency and leaking. Severe BPH can lead to serious problems over time, such as strain on the bladder, urinary tract infections, bladder or kidney damage, bladder stones, and the inability to control urine (incontinence). Current treatment options to relieve symptoms associated with BPH include drug therapy or surgical procedures including removal of the enlarged part of the prostate.

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

The FDA’s review 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 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 percent of participants.

The studies also measured participant urine flow and ability to empty the bladder, and throughout the study period, found a 30 percent increase in urine flow and a steady amount of residual urine in the bladder. Study participants answered validated questionnaires about their BPH-related symptoms and quality of life, reporting 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.

“Many BPH patients are concerned about the potential side effects of currently available treatments and are not interested in taking pills the rest of their lives,” said Steven Gange, M.D., of the Western Urological Clinic in Salt Lake City, Utah, and an investigator in one of the UroLift trials. “UroLift is a well-tolerated, easy to learn procedure that gives the surgeon immediate visual feedback, which generally correlates with excellent patient outcomes.”