NeoTract, Inc. Announces Publication Showing Sustained Safety and Efficacy Benefits for the Minimally Invasive UroLift® System Treatment for Enlarged ProstateJanuary 21, 2015 8:00 am
PLEASANTON, Calif. – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced publication of two-year results from the 206-patient L.I.F.T. IDE Study, a multi-center, randomized, blinded study of the novel UroLift® System for patients with Benign Prostatic Hyperplasia (BPH).
The study, published in Urology Practice, an official journal of The American Urological Association, concluded that the UroLift System preserves sexual function and provides rapid improvement in symptoms, flow and quality of life that are sustained to two years.
“These results show that the initial benefits of treatment with UroLift, which provides rapid relief of BPH symptoms with minimal side effects, are durable two years after treatment, with less than one in ten patients requiring an additional procedure for symptom relief,” said lead author Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, and coprincipal investigator for the L.I.F.T. clinical program. “I look forward to reporting three-year results of the study in May at the American Urological Association’s annual conference in New Orleans.”
The analysis from the L.I.F.T. study shows an 88% superiority of treatment (n=140) over control (n=66) at three months and a sustained therapeutic effect in the UroLift implanted patients at two years. The peak urinary flow rate was increased 4.2 ml per second at three months and two years (p <0.0001). By two years only 7.5% of patients required an additional procedure for lower urinary tract symptoms. Adverse events were typically early, mild and transient. Encrustation did not develop on implants properly placed in the prostate. There was no occurrence of de novo sustained ejaculatory or erectile dysfunction.
“These excellent clinical results add to the growing body of evidence confirming the benefits of the minimally invasive UroLift implant system as a treatment option for patients suffering from an enlarged prostate, which impacts millions of Americans and often greatly impacts quality of life,” said Dave Amerson, president and CEO, NeoTract. Inc. “We continue to receive highly positive feedback from the clinical community about the procedure, which as of January 1 is now fully coded with Category 1 CPT® codes.”
About Benign Prostatic Hyperplasia (BPH)
BPH, also known as enlarged prostate, is a medical 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 alone. 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 and by age 70, over 80 percent of men suffer from BPH. Medication is often the first-line therapy for enlarged prostate, 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 transurethral resection of the prostate (TURP), can be very effective in relieving symptoms, it can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
About the UroLift System
The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., 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. The company’s 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.
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