Real-World Data Presented at American Urological Association Meeting Highlight Consistency with Controlled Studies and Effectiveness in Diverse Patient Populations
WAYNE, Pa. – May 6, 2019 – Teleflex Incorporated (NYSE: TFX) today announced the presentation of new clinical data at the American Urological Association (AUA) 2019 Annual Meeting from five studies of the UroLift® System for patients with benign prostatic hyperplasia (BPH), showcasing the safety and effectiveness of the minimally invasive treatment in real-world patient populations.
“Findings from these studies are consistent with results found in controlled clinical studies, reaffirming the safety and long-term benefits of the minimally invasive UroLift System treatment for BPH in diverse patient populations,” said Dave Amerson, president of Teleflex Interventional Urology business unit. “We are pleased to add this data to the growing portfolio of real-world outcomes frequently found among more than one hundred thousand patients that have been treated for BPH with the UroLift System.”
Mark Rochester, M.D., Norwich & Norfolk University Hospital, presented Early Outcomes of Prostate Urethral Lift in Subjects Acute Urinary Retention. The study examined 52 patients to evaluate the feasibility of the UroLift System treatment for patients with acute urinary retention. The results demonstrated that 79% of patients were catheter-free within three months, and 96% reported being “much or very much better” at six months.
“Patients with acute urinary retention are faced with extremely limited treatment options and have been previously excluded from PUL studies,” said Dr. Rochester. “These results demonstrate that the UroLift System treatment can quickly and safely restore urinary flow in the majority of patients with acute urinary retention, providing this challenging patient population a safe and effective alternative to long-term catheter management and invasive BPH treatment options.”
UroLift System Featured in Four Additional Presentations at AUA Meeting
The presentation, Real World Outcomes of Prostatic Urethral Lift Confirm Clinical Study Results, was presented by Steven Gange, M.D., a urologist at Summit Urology Group in Salt Lake City. The study highlighted real-world results of 1,413 patients who received the UroLift System treatment across 14 sites in North America and Australia. Results were consistent with those seen in previous clinical studies of the UroLift System, despite the more diverse patient population.
Gregory McMahon, D.O., urological surgery resident of Rowan University of Osteopathic Medicine, Stratford, N.J., presented Large Retrospectively Managed Single Surgeon Experience with Prostatic Urethral Lift, featuring the largest single surgeon series reported on PUL. The study examined 156 patients that received the UroLift System treatment from a single surgeon. Results from the study shows statistically significant improvement in BPH symptoms, quality of life and post-void residual volume for patients treated with the UroLift System, and were similar to the results reported from the pivotal L.I.F.T. study.
Prostatic Urethral Lift (PUL) Symptom and Sexual Function Results Maintained in the Treatment of All Types of Prostate Enlargement Including Obstructive Middle Lobe, was presented by Daniel Rukstalis, M.D., professor of urology at Wake Forest School of Medicine. The presentation featured results from the pivotal randomized L.I.F.T. study combined with data from the MedLift Study of the UroLift System for patients with an obstructive middle lobe (OML). Findings from the study suggest that patients with all types of prostate enlargement experience excellent symptom improvement and preservation of sexual function.
Prostatic Urethral Lift (PUL) and Magnetic Resonance Imaging (MRI): Defining artefact and risk of obscuring significant cancer was presented by Peter Chin, M.B.B.S., associate professor at Wollongong University Graduate School of Medicine in Australia. The study examined 10 patients to define the size and location of artefact caused by the UroLift System on MRI for patients undergoing screening for prostate cancer. Results from the study show the UroLift System is unlikely to obscure prostate cancer for patients receiving MRI screening.
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.*1,2 Patients also experienced significant improvement in quality of life. Over 100,000 men have been treated with the UroLift System worldwide. 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 Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.UroLift.com.
About Teleflex Interventional Urology
The Teleflex 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®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
Dr. Peter Chin, Dr. Steven Gange, Dr. Mark Rochester, and Dr. Daniel Rukstalis are paid consultants of Teleflex Incorporated.
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Contacts:
For Teleflex Incorporated:
Jake Elguicze, 610.948.2836
Treasurer and Vice President, Investor Relations
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Nicole Osmer, 650.454.0504
nicole@healthandcommerce.com
*No instances of new, sustained erectile or ejaculatory dysfunction
1. Roehrborn, J Urology 2013 LIFT Study
2. Shore, Can J Urol 2014 Local Study
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