NeoTract, Inc. Receives U.S. FDA De Novo Approval for the UroLift® Prostate Implant
, Sept. 16, 2013
/PRNewswire/ -- NeoTract, Inc., today announced that it received De Novo approval from the U.S. Food and Drug Administration (FDA) to market the novel UroLift® System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate. The FDA's action will provide U.S. surgeons and patients access to a treatment option that uniquely reduces urinary symptoms without chemically altering or surgically ablating, cutting or removing prostatic tissue. Data from the recent 206-patient randomized controlled L.I.F.T. study showed patients receiving UroLift implants reported rapid symptomatic improvement, improved urinary flow rates, and sustained sexual function. Patients also experienced a significant improvement in quality of life.
BPH is a urological condition in which the prostate gland becomes enlarged with advancing age and begins to obstruct the urinary system. The condition is common, with about one in four men experiencing BPH-related symptoms by age 55, and affecting up to 90 percent of men in their 70s and 80s. BPH symptoms include sleepless nights and urinary problems can cause loss of productivity, depression and decreased quality of life.
"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," stated Dr. Steven Gange, Western Urological Clinic, Salt Lake City, a L.I.F.T. study investigator. "UroLift is a well-tolerated, easy to learn procedure that gives the surgeon immediate visual feedback, which generally correlates with excellent patient outcomes."
The UroLift Prostate Implant provides a minimally invasive alternative to tissue removing surgery for the treatment of BPH. UroLift permanent 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.
"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 US. We have been very impressed with the thorough and efficient De Novo review process conducted by the FDA," said Dave Amerson, President and CEO of NeoTract, Inc. "We believe UroLift is a first line treatment option for patients with BPH given its strong therapeutic benefit and safety profile."
About BPH and the UroLift System Treatment
BPH afflicts approximately 37 million aging men in the United States. Medication is often the first line therapy but relief can be inadequate and temporary. Side-effects of treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts or ablates prostate tissue to open the blocked urethra. While current surgical options, such as the 'gold standard' surgery, Transurethral Resection of the Prostate (TURP), can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
The UroLift System transurethrally pushes aside the obstructive prostate lobes like opening window curtains, and small permanent UroLift implants hold the lobes in the retracted position, thus opening the urethra while leaving the prostate intact.
The UroLift System is now available in the US and is also for sale in Europe, Australia and Canada. Learn more at www.UroLift.com.
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.
SOURCE NeoTract, Inc.