NeoTract Announces Results from Five Real-World Studies Reaffirming Efficacy and Safety of UroLift® System Treatment for Enlarged Prostate
WAYNE, Pa.--(BUSINESS WIRE)--Sep 25, 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 World Congress of Endourology 2018 Annual Conference from five studies of the company’s novel UroLift ® System for patients with Benign Prostatic Hyperplasia (BPH).
“The real-world results from these studies of diverse patient populations on three continents reaffirm the sustained benefits of the UroLift System as an accepted standard of care treatment for patients with BPH,” said Dave Amerson, president of the NeoTract Interventional Urology business unit. “We are pleased that we continue to see results from real-world studies in line with our randomized pivotal study, demonstrating that the UroLift System is a safe and effective minimally invasive treatment that offers men long-term relief from the symptoms of BPH.”
Five Studies Show Significant Relief and Improved Quality of Life with UroLift System
The “Real-World Experience” study, which enrolled 156 patients at the Norfolk & Norwich University Hospital in the U.K., compares outcomes of patients with BPH who received treatment with the UroLift System in a real-world setting to those seen in clinical studies.
The data, presented by Mark Rochester, M.D., consultant urological surgeon of Norfolk and Norwich University Hospitals NHS Foundation Trust U.K., demonstrates International Prostate Symptom Score (IPSS) improvement for patients treated with the UroLift System in a real-world setting, as well as improved quality of life (QoL) and peak flow rate (Qmax) at both the three and six-month follow up timepoints. At three months, patients experienced an average improvement of 10.0 points in IPSS, 2.2 points in QoL and 4.8 mL/s in Qmax. These results were statistically not different from those observed in the pivotal L.I.F.T. study.
“The excellent results of this large study were consistent with the pivotal L.I.F.T. study,” said Dr. Rochester. “These outcomes demonstrate that the UroLift System can be used to treat patients with BPH in the real world safely and effectively.”
The “Does Size Matter?” study, which evaluates the UroLift System as a treatment for BPH in men with small and large prostate volumes, was presented by Gregory McMahon, D.O., urological surgery resident of Rowan University of Osteopathic Medicine (Stratford, N.J.), and Thomas Mueller, M.D., urologist of New Jersey Urology (Voorhees, N.J.). Both patient cohorts from this single-center study were treated in an office setting for a six-month period. Data from this study shows that men with small and large prostates experienced statistically significant improvement in symptoms and quality of life when treated for BPH with the UroLift System. At six months, mean IPSS decreased by 17.6 and 13.2, and QOL improved by 2.5 and 2.6 in the small and large prostate groups, respectively.
“Results from this study demonstrate the versatility of the UroLift System as an effective treatment for a wide range of patients and that it can be safely performed in an office setting. It is especially gratifying to see that results at an experienced center such as ours can meet or exceed those observed in the L.I.F.T. study,” said Dr. Mueller.
Three additional real-world studies were presented at the conference, each showing favorable results and improved outcomes for patients with BPH who received treatment with the UroLift System:The Management of Acute Urinary Retention Study, presented by Ashok J. Kar, M.D., director of robotic and minimally invasive surgery St. Joseph Hospital of Orange (Orange, Calif.), reviewed the outcomes of patients who were treated with the UroLift System for acute urinary retention due to BPH. All patients from this study had indwelling foley catheters in place and were treated exclusively in an office setting for an 18-month period. The results demonstrated that 90% of the patients became catheter-free within three months after treatment. Data presented by Campbell F. Bryson, M.D., chief urology resident of Yale New Haven Hospital (Princeton, N.J.), from a single-center, first-time, real-world study closely resembles results from the pivotal L.I.F.T. trial, showing robust improvements in symptoms and quality of life for patients treated for BPH with the UroLift System. Results from an Early Experience study presented by Justin Chee, M.D., consultant urological surgeon of Western Health (Melbourne, Australia), show that patients treated for symptomatic BPH with the UroLift System in a public hospital setting experienced improvement in symptoms and quality of life with preserved 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 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®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
Mark Rochester and Thomas Mueller are paid consultants to NeoTract | Teleflex Interventional Urology.
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PUB: 09/25/2018 06:45 AM/DISC: 09/25/2018 06:45 AM