New Study Provides Insights into the Biocompatibility and Durability of the UroLift® System in ...
WAYNE, Pa., Aug. 30, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX) today announced the publication of clinical data for the UroLift® System in the peer-reviewed journal Prostate Cancer and Prostatic Disease. This study explains the mechanism of action through which the UroLift System provides long-term durability and sustained results for patients with benign prostatic hyperplasia (BPH), also referred to as enlarged prostate.
The UroLift System implants provide rapid relief from disruptive lower urinary tract symptoms (LUTS) through a minimally invasive procedure that pulls back enlarged prostate tissue. This published study is unique in its amalgamation of three different facets of research by including pre-clinical canine tissue, human tissue, and post-market surveillance data. Tissue samples were examined from twenty-four healthy canines and four human patients who were implanted with the UroLift System. Researchers reviewed the microscopic structure on all tissue samples to uncover any potential changes attributed to the implants.
The microscopic evaluation found that the extracted tissues revealed normal-appearing tissue with minimal-mild inflammation and no encrustation, indicating a stable and normal healing response. The data support a long-term biological mechanism of action whereby compression-induced localized tissue remodeling is initiated by the UroLift System implant placement and leads to a widened prostatic urethra. Furthermore, post-market surveillance data of over 770,000 UroLift System devices support that the implant is stable and remains fixed after proper deployment, and demonstrate low rates of breakage (0.004%) and encrustation (0.006%). Taken together, the biocompatibility and stability of the UroLift System implants appear to be superior to prostatic stents, with studies of prostatic stents showing that up to 47% of men require removal of their implants due to complications associated with migrations and encrustations.1
The UroLift implant pulls the enlarged prostate toward the capsule, thereby mechanically creating an immediate, visible deobstruction in the prostatic urethra. The researchers discuss this “prostate lift” is a fundamentally distinct mode of action compared with not only prostatic stents, but also thermal ablation techniques that induce tissue damage and may result in extended periods of edema, retention/catheterization, and higher risks of urinary infections and ejaculatory dysfunction.2,3,4,5,6,7
“The UroLift System is the first mechanical prostatic implant to demonstrate safe and effective treatment of BPH without common issues associated with prior stents. This study describes in detail the unique prostate lift mechanism of action that is the basis of its durable outcomes,” said Dr. Peter Chin, Clinical Associate Professor, Graduate School of Medicine, University of Wollongong, and author on the paper. “Not only are the results seen with the UroLift System sustainable, but the implants can provide a superior patient experience during the early recovery period4, and rapid symptom relief and preservation of sexual function*”9
“More than 12 million men in the U.S. are treated for BPH/LUTS.8 With over 250,000 patients treated globally with the UroLift System, it has been the right solution for many patients,” said Jacqueline Welch, Medical Director of the Teleflex Interventional Urology business unit. “Physicians can implant the UroLift System with confidence due to the demonstrated long-term durability and sustained BPH relief that it provides.”10
About the UroLift® System
The UroLift® System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. The UroLift permanent implants, delivered during an outpatient procedure, relieve prostate obstruction without heating, cutting, destruction or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.*9,10,11,12 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.9 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. 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. More than 250,000 men have been treated with the UroLift System in select markets worldwide. † 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 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.*9-11 Learn more at 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 Teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
+Dr. Chin was an investigator for the PUL feasibility clinical trial and the LIFT pivotal study. He is also a paid consultant for NeoTract Inc./Teleflex.
For Teleflex Incorporated:
Vice President, Investor Relations and Strategy Development
John Hsu, CFA
Vice President, Investor Relations
Nicole Osmer, 650.454.0504
CEO, Health + Commerce
*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
†Management estimate based on product sales and average units per procedure
1 Armitage, J Urol 2007
2 Hoffman, Cochrane 2012
3 Rosario, Br J Urol 1997
4 Tutrone, Can J Urol 2020. Nonrandomized controlled study comparing the early patient experience following treatment with the UroLift System and Rezum™ steam injection.
5 Bruyere, Eur Urol 2010
6 McVary, J Urol 2016
7 Rassweiler, Eur Urol 2006
8 NeoTract US Market Model estimates for 2020, data on file
9 Roehrborn, J Urology 2013 LIFT Study
10 Roehrborn, Can. J Urology 2017 LIFT Study 5-year results
11 AUA BPH Guidelines 2003, 2020
12 McVary, J Sex Med 2016
MAC01902-01 Rev B