MUNICH, March 14, 2016 /PRNewswire/ --
Further evidence from two multi-national randomized studies presented at EAU conference supports durability of UroLift® System treatment for men with enlarged prostate
The UroLift system treatment for enlarged prostate was showcased today at the European Association of Urology international conference with the presentation of the four-year durability results of the multi-national L.I.F.T. randomised study and the two year results of the multi-national BPH6 randomised study. These promising results were presented as the EAU Guidelines for male lower urinary tract symptoms (LUTS) upgraded the rating for UroLift data to the highest possible classification, Level 1A. The EAU guidelines update comes as NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, announces key gains in European government healthcare system reimbursement in multiple markets.
In the UK, UroLift is now being offered by multiple publicly-funded NHS hospitals following positive NICE (National Institute for Health and Care Excellence) guidance based on a review of the economic and clinical benefits and revised tariff coding in September of last year. In Denmark, UroLift is being offered in a growing number of Government-funded hospitals following a trial at Herlev Hospital in Copenhagen.
NeoTract's EMEA Vice President and General Manager, Justin Hall, says: "We at NeoTract are delighted that the EAU has recognized the high quality of clinical data behind UroLift. This is a watershed moment for the UroLift System, which is becoming more widely available to patients as healthcare systems recognize the clinical benefits to patients and the economic advantages to the health systems of respective countries.
"Daily, we see evidence of increasing demand across Europe from patients and their partners for the UroLift System, a less invasive, true day case procedure that can be carried out under local anesthesia showing zero de novo risk of impact on sexual function and rapidly improves quality of life for couples whose lives are severely impacted by BPH. UroLift's safety profile, clinical efficacy and substantial care pathway cost savings were recognized last year by the UK body (NICE) and are now more than persuasive as we operate under ever more complex and demanding government healthcare-funding arrangements across Europe. Today, payors rightly demand the most rigorous economic and clinical data to support the adoption of new technology. Our new Level 1A endorsement from the EAU, based on our robust mid range clinical data, will further progress our mission to make this life-changing treatment available to all suitable men with BPH across Europe."
Professor of Urology, Dr Jens Sønksen from Herlev Hospital in Denmark, says: "We will welcome this news and I, and my colleagues here in Copenhagen who have been investigators in one of the trials being showcased at the EAU this year, are not surprised at the EAU's upgrade of the rating it gives the UroLift System. The quality of the clinical data supporting the UroLift System is clear. We are looking forward to leading efforts to train urologists in this procedure at Herlev Hospital and make it more widely available to eligible patients across the region."
UK Consultant urologist Neil Barber, who was the first surgeon to introduce UroLift into the UK government-funded NHS, says: "From the surgeon's perspective, UroLift is a truly groundbreaking treatment - it's a simple, fast procedure; easy to insert, completely feasible under local anaesthesia with or without sedation and can be routinely performed as a true day case. The indications are much wider than I initially thought, so rather than being appropriate for a niche group of men within the BPH spectrum, UroLift is suitable for a significant number of patients with LUTS secondary to bladder outlet obstruction. When appropriately counselled, UroLift is now the first line treatment choice for an increasing proportion of men who previously were reticent to seek the traditional alternatives of long-term medical therapy and particularly keen to avoid the more invasive surgical approaches. Following treatment, the norm is that men and their partners are delighted with what usually amounts to a rapid return to normal activity and significant improvement in symptoms."
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 500 million men worldwide. 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 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 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 received positive NICE guidance and is FDA-cleared. It is available in the U.S., Europe, Australia, Canada and Mexico. Learn more at http://www.UroLift.co.uk.
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 http://www.NeoTract.com.
MAC00278-01 Rev A
SOURCE NeoTract, Inc.