Last week we announced the FDA clearance of NeoTract’s UroLift® System for treating symptoms of benign prostatic hyperplasia. Hot on the heels of that news the company is keen to tell us a first patient has now undergone treatment with the device.
For millions of sufferers, medication is often the first line therapy in treating an enlarged prostate. But relief can be inadequate, temporary and riddled with side-effects. When medication doesn’t work out, surgery to cut or ablate prostate tissue in order to open the blocked urethra is the only alternative. The well-known TURPS (Transurethral Resection of the Prostate) procedure has long been the gold standard, and while it works well in relieving symptoms can have permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation.
NeoTract’s UroLift® System is the first permanent implant to treat symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. The system is designed to relieve symptoms caused by an enlarged prostate, while preserving sexual function.
The UroLift System comprises permanent implants, delivered during a minimally-invasive procedure. According to the manufacturer these act like window curtain tie-backs to hold the lobes of an enlarged prostate open. Patients reportedly recover from the procedure quickly, and return to their normal routines with minimal downtime.
Data from a recent pivotal 206-patient randomized controlled study, conducted primarily in the U.S., 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. Patients also experienced a significant improvement in quality of life.
“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. “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.”
“We, at NeoTract, are extremely pleased to bring our straightforward, innovative UroLift System to physicians and patients in selected U.S. centers,” commented Dave Amerson, president and CEO of NeoTract. “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.”
Source: NeoTract, Inc., PR Newswire