PLEASANTON, Calif. – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced that First Coast Service Options, Inc., the Medicare Administrative Contractor (MAC) covering Florida, Puerto Rico and the U.S. Virgin Islands, has established coverage for the UroLift® System for the treatment of enlarged prostate, or benign prostatic hyperplasia (BPH).
With this coverage determination, the minimally invasive UroLift System is now available to Medicare beneficiaries across the country.
“We are thrilled that millions of men across the United States now have access to the UroLift System treatment,” said Dave Amerson, President and CEO, NeoTract, Inc. “The recently published four-year clinical data showing the durable benefits of the UroLift System, in addition to the procedure’s already-established uniquely rapid relief, have compelled Medicare administrative contractors and many commercial insurers to offer access to this important solution for men suffering from enlarged prostate.
“In addition to these proven clinical benefits, insurers and healthcare systems are increasingly acknowledging that treatment with the UroLift System can also improve efficiency of care, something that can benefit the entire healthcare system. Recently, the UK’s Accelerated Access Review designated the UroLift System as one of only six medical technologies whose adoption should be accelerated to improve National Health Service (NHS) healthcare efficiency.”
The UroLift System is a proven treatment that can get men off BPH medications and allow them to avoid major surgery, while preserving sexual function. Long-term clinical data from the LIFT randomized study published in Urologic Clinics of North America showed that, after four years, patients treated with the UroLift device continue to experience symptom relief with minimal side effects, with few patients requiring an additional procedure for relief.1 A second randomized clinical trial called BPH6 published in European Urology demonstrated that the UroLift device compares very well to the classic surgery, transurethral resection of the prostate (TURP), with regard to efficacy, and is superior to TURP at preserving sexual function and offering a more rapid recovery.2
More than 37 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life.
Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication 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, heats or removes prostate tissue to open the blocked urethra. While current surgical options 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).
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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1 Roehrborn Urology Clinics 2016
2 Sonksen et al Eur Urology 2015
MAC00390-01 Rev A