First U.S. Patient Treated Following FDA’s OK of BPH Treatment Device

The first patient in the United States has been treated with the UroLift System from NeoTract Inc. following U.S. Food and Drug Administration (FDA) clearance. According to the company, it is the first implant to treat symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. On Sept. 13, the FDA cleared the system, which is designed to relieve symptoms caused by an enlarged prostate, while preserving sexual function.

BPH is a condition in which the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. The condition is common, affecting approximately 37 million men in the United States. BPH symptoms include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life. About one in four men experience BPH-related symptoms by age 55, with 90 percent of men older than 70 symptomatic.

“Our hospital system is committed to providing patients with the highest quality, most effective options to address their urology needs,” said Eugene Rhee, M.D., M.B.A., chief of the Department of Urologic Surgery at Kaiser Permanente in San Diego, Calif. “The commercial availability of the UroLift System, with its excellent safety profile, provides men suffering from an enlarged prostate a beneficial first-line treatment alternative to drug therapy or more invasive surgery. Importantly, the UroLift System provides fast and meaningful relief from BPH symptoms, improving overall quality of life for our patients.”

The system, delivered during a minimally invasive procedure, acts like window curtain tie-backs to hold the lobes of an enlarged prostate open. Patients recover from the procedure quickly, and return to their normal routines with minimal downtime, according to the company.

Data from a recent pivotal 206-patient randomized controlled study, conducted primarily in the United States, showed that patients receiving UroLift implants reported rapid symptomatic improvement, improved urinary flow rates, and sustained sexual function with minimal adverse events, which mostly resolved two to four weeks following the procedure. 

“We are committed to providing excellent physician training and patient education, both important for positive patient outcomes, and believe this product will make a significant difference in the lives of aging men,” said Dave Amerson, president and CEO of NeoTract.

The UroLift System provides an alternative to tissue removing surgery for the treatment of an enlarged prostate. Performed through the urethra, a urologist uses the UroLift System to push aside the obstructive prostate lobes and positions small, tailored permanent UroLift implants to hold the prostate lobes in the retracted position. This opens the urethra while leaving the prostate intact. Adverse reactions associated with UroLift System treatment were comparable to other minimally invasive surgical therapies as well as standard cystoscopy, the company reported.

The most common adverse events reported during the study included pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate, and the inability to control urine because of an urgent need to urinate. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure, according to study results.

More than 500 million aging men worldwide have an enlarged prostate. Medication is often the first line therapy but relief can be inadequate and temporary. 
About NeoTract

Pleasanton, Calif.-based NeoTract develops urology devices. The UroLift System is also available in Europe, Australia and Canada.