PLEASANTON, Calif. – March 19, 2018 – NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE: TFX) focused on addressing unmet needs in the field of urology, today announced the results from the first analysis of a retrospective registry of more than 800 UroLift® System procedures performed at seven centers in North America, Europe and Australia.
The study, which was presented by Oliver Kayes, M.D., of Leeds Teaching Hospital in Leeds, U.K., found that the UroLift System offers significant improvement in symptoms and quality of life through 24 months among patients in the “real world” (non-clinical trial setting):
- With a 40% reduction in IPSS score at 24 months, results were consistent with the data from the randomized, five-year L.I.F.T. study. L.I.F.T. demonstrated that the UroLift System treatment provides a highly tolerable minimally invasive procedural experience, rapid reduction of symptoms after the procedure, and sustained improvements in QoL (Quality of Life) score, IPSS (International Prostate Symptom Score), and Qmax (peak urinary flow rate), while preserving sexual function.1
- The registry retreatment rate was consistent with L.I.F.T., which demonstrated a retreatment rate of just 2-3% per year, comparing well to the 1-2% expected rate for the gold standard TURP.2
- Additionally, the registry included patients in urinary retention prior to treatment. Of those with follow up data, 96% were able to urinate without use of a catheter within the first month.
The registry will continue to enroll additional sites and is expected to increase to more than 2,000 patients.
“The findings of this large multi-center, multi-national retrospective study of results from hundreds of men should give urologists and patients confidence that the outcomes for UroLift System in published, controlled clinical studies are representative of real-world usage,” said Mr. Kayes, who presented the results at the European Association of Urology annual meeting in Copenhagen. “The data strongly supports the UroLift System as a compelling rapid, minimally invasive option for BPH that offers symptom relief with minimal side effects and does not cause sexual dysfunction.”
“With this data, the UroLift System continues to prove itself as the new standard of care for men with enlarged prostate,” said Dave Amerson, president of the NeoTract Interventional Urology business unit. “Clinical adoption of the UroLift System procedure continues to grow rapidly worldwide. We are gratified to know this means that tens of thousands of men are now living better lives, relieved of the symptoms of BPH.”
Recently the U.S. Food and Drug Administration (FDA) cleared new indications for the UroLift System, making patients who have an obstructive median lobe and those as young as 45 now eligible to receive treatment with the UroLift System for their BPH symptoms.
Benign prostatic hyperplasia (BPH), also known as enlarged prostate, is non-cancerous enlargement of the prostate that occurs as men age. The condition, which affects more than 40% of men over 50 and over 70% of men in their 60s, is marked by bothersome urinary symptoms that can cause loss of productivity, depression, interrupted sleep, and decreased quality of life.
BPH is not a pre-cursor to prostate cancer, but is twelve times more common, especially as men age. Over 40 percent of men in their 50s have BPH and over 70 percent of men in their 60s have the condition. The incidence rate climbs to 80 percent for men over the age of 70. If BPH is left untreated, the condition can worsen over time and cause permanent bladder damage.
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.
About the UroLift System
The FDA-cleared UroLift System is a proven, 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. More than 50,000 men worldwide have been treated with the UroLift System. 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, Canada, Mexico and South Korea. Learn more at www.UroLift.com.
About NeoTract | Teleflex Interventional Urology
A wholly owned subsidiary of Teleflex Incorporated, the NeoTract Interventional Urology Business Unit 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.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit www.teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.
Oliver Kayes is a paid consultant to NeoTract | Teleflex Interventional Urology.
Treasurer and Vice President, Investor Relations
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1. No instances of de novo (or new), sustained erectile or ejaculatory dysfunction. Roehrborn, J Urology 2013 LIFT Study; Roehrborn, 2015 Can J Urol, 3 yr results of PUL LIFT study
2. Roehrborn et al. Can J Urol 2017
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