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Teleflex Incorporated (NYSE: TFX) today announced the publication of an article showcasing the effectiveness and overall benefits of the minimally invasive UroLift® System treatment for patients with benign prostatic hyperplasia (BPH). The article, DeMISTifying less-invasive solutions for BPH, reviews the objectives of using minimally invasive surgical technologies (MIST) to treat BPH, and recommends useful metrics to measure the success of these treatments, including the UroLift System. The article, published in Urology Times, is authored by Steven Kaplan, M.D., professor of Urology, Icahn School of Medicine at Mount Sinai and director of the Men’s Health Program at Mount Sinai Health System, New York.
In the article, Dr. Kaplan notes that, due to shortcomings of transurethral resection of the prostate (TURP) and medications, the advancement of the MIST category remains imperative for men seeking an effective treatment option for BPH. Many men have concerns about the long-term efficacy and side effects of traditional surgical procedures and medications for BPH. Of the 12.4 million men in the United States with moderate to severe BPH, less than 2% choose TURP as a preferred treatment choice and 60% of patients using medical therapy are not compliant in taking their BPH medications1.
“This article articulates what the advent of the UroLift System treatment has uncovered, namely that many patients are seeking an effective and durable treatment for BPH that also offers rapid relief, freedom from catheterization and preservation of sexual function,” said Dave Amerson, president of Teleflex Interventional Urology business unit. “Over 100,000 patients have been treated with the UroLift System, and the rapidly increasing adoption demonstrates that this treatment is delivering on patient and provider goals.”
The article suggests that, given past failures of MIST procedures, current minimally invasive options must demonstrate treatment efficacy as well as greatly reduce morbidity and render a more attractive overall patient experience in order to succeed. The article presents a proposed minimally invasive scoresheet to evaluate MIST procedures based on the ability to deliver predictable results, rapid recovery and symptom relief, durability through five years, improved quality of life, and reliable preservation of sexual function, without being associated to the serious harms of surgery.
In the analysis, the UroLift System scores favorably on the MIST scoresheet, with patients reporting rapid recovery and symptom relief, preserved sexual function, low catheterization rates and low complications. The overall net health outcome - the balance of efficacy, morbidity, and patient experience - appears superior for the UroLift System compared to that for thermal ablation procedures, such as steam injection. The UroLift System treatment is also the only BPH procedure that has not been associated with de novo, sustained erectile or ejaculatory dysfunction2.
“I am encouraged by the recent renaissance in the treatment options available for symptomatic BPH patients, and the UroLift System treatment appears to offer a unique patient experience,” said Dr. Kaplan. “Although only time will tell how well the various options are adopted by patients, the UroLift System is supported by robust clinical evidence and is well-positioned to meet the needs of patients looking for an effective alternative to drugs and surgery.”
Results from multiple real-world studies of diverse patient populations are consistent with data from the randomized pivotal L.I.F.T. Study, demonstrating the safety and effectiveness of the UroLift System for patients with BPH in a real-world setting. The Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in the American Urological Association and the European Association of Urology clinical guidelines.
Dr. Steven Kaplan is a paid consultant of Teleflex Incorporated.
About the UroLift® SystemThe 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.*2,3 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 UrologyThe 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 sexual function.*2,4 Learn more at www.NeoTract.com.
About Teleflex IncorporatedTeleflex 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.
For Teleflex Incorporated:Jake Elguicze, 610.948.2836Treasurer and Vice President, Investor Relations
Media:Nicole Osmer, firstname.lastname@example.org
1. Cindolo J. Eur Urol 2015; 68; 418-25 2. Roehrborn, J Urology 2013 LIFT Study3. Shore, Can J Urol 2014 Local Study4. McVary, J Sex Med 2014*No instances of new, sustained erectile or ejaculatory dysfunction