PLEASANTON, Calif. – Oct. 15, 2018 – NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced the presentation of new clinical data at the 2018 Annual Meeting of the Northeastern Section of the American Urology Association (AUA) in Toronto, Ontario, from a study of the company’s novel UroLift® System for patients with Benign Prostatic Hyperplasia (BPH).
The real-world study, which enrolled 100 patients at a single center, evaluated the UroLift System treatment for lower urinary tract symptoms (LUTS) in men with BPH. The study, presented by Bashar Omarbasha, M.D., chief of urology at Oneida Healthcare and Rome Memorial Hospital in Oneida, New York, analyzed outcomes from patients to examine how the UroLift System performs in a real-world setting and whether outcomes are similar to those seen in clinical studies.
Data from the study showed a 62% improvement in International Prostate Symptom Score (IPSS) two months after treatment. Peak flow rate improved 140% and the post-void residual volume (PVR) decreased by 71 ml, with no patients requiring re-operation. These changes are statistically better than the pivotal L.I.F.T trial results.
“Clinical data from previous studies have proven that the UroLift System offers rapid and durable relief of symptoms and improved quality of life for patients with BPH,” said Dr. Omarbasha. “The results of this study, from my first 100 UroLift System patients, are even better than the pivotal L.I.F.T clinical study at the three-month follow up timepoint, adding to the clinical evidence that shows the UroLift System can be used in the real world safely and effectively.”
Several recent single-center studies have established that results from the L.I.F.T clinical study are being replicated by investigators in the real world. Results from the Real-World Experience Study, presented at the World Congress of Endourology 2018 Annual Conference by Mark Rochester, M.D., consultant urological surgeon of Norfolk and Norwich University Hospitals NHS Foundation Trust U.K., were consistent with the pivotal L.I.F.T study, showing improvement of IPSS, peak flow rate, and quality of life in patients treated for BPH with the UroLift System in a real-world setting.
Data presented at the 2018 Annual Meeting of the New England Section of the AUA by Campbell F. Bryson, M.D., chief urology resident of Yale New Haven Hospital in Princeton, N.J., from a single-center, first-time study closely resembles results from the pivotal L.I.F.T trial, showing robust improvements in symptoms and quality of life for patients with BPH who received the UroLift System treatment in a real-world setting.
“The results of these numerous real-world studies help to further validate the many advantages of the UroLift System for patients with BPH in the real world,” said Dave Amerson, president of the Teleflex Interventional Urology business unit. “We are proud to be improving the lives of patients suffering with the symptoms of BPH by providing a safe and effective treatment that provides rapid relief and allows men to stop or reduce BPH medications, without compromising sexual function.”
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. Nearly 70,000 men have been treated with the UroLift System in the U.S. 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 Prostatic Urethral Lift procedure 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 NeoTract | Teleflex Interventional Urology
A wholly owned subsidiary of Teleflex Incorporated, 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.
Mark Rochester is a paid consultant to NeoTract | Teleflex Interventional Urology.
For Teleflex Incorporated:
Jake Elguicze, 610.948.2836
Treasurer and Vice President, Investor Relations
Nicole Osmer, 650.454.0505
MAC00876-01 Rev A