Large-Scale Real-World Study Demystifies UroLift™ System Durability and Reinforces Superior Patient Experience for Men With Enlarged Prostate Compared to Leading Surgical Treatments

Rhea-AI Summary

Teleflex Incorporated (NYSE:TFX) announced a new peer-reviewed study in the Nature journal Prostate Cancer and Prostatic Diseases reinforcing the UroLift™ System as the gold standard in minimally invasive surgical treatment for benign prostatic hyperplasia. The study evaluates complication and retreatment rates after BPH treatment with leading surgical and MIST, suggesting that within one year of BPH surgery, 1 in 20 patients may require retreatment regardless of the treatment method.

WAYNE, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, announced today that a new peer-reviewed study in the Nature journal Prostate Cancer and Prostatic Diseases reinforces the position of the UroLift™ System as the gold standard in minimally invasive surgical treatment (MIST) for benign prostatic hyperplasia (BPH), or enlarged prostate. Retreatment Rates and Postprocedural Complications Are Higher Than Expected After BPH Surgeries: A U.S. Healthcare Claims and Utilization Study is the largest longitudinal healthcare claims study evaluating complication and retreatment rates after BPH treatment with leading surgical and MIST ever conducted, and the only study to include all outpatient sites of service.¹

Rates of surgical retreatment, alongside patient experience factors such as complications and adverse events (AEs), are important considerations when patients and their providers assess BPH therapies. However, comparing different randomized controlled trials (RCTs) for these outcomes can be limited and misleading due to varying methodologies. This first-of-its-kind study overcomes these limitations and directly compares and analyzes outcomes in over 40,000 real-world BPH patients by applying a consistent definition of retreatment across the leading BPH treatments. Results suggest that within one year of BPH surgery, 1 in 20 patients may require retreatment regardless of whether they receive a transurethral resection of the prostate (TURP), GreenLight™ photoselective vaporization of the prostate (PVP), Rezūm™ water vapor thermal therapy (WVTT) or UroLift™ System prostatic urethral lift (PUL) (5.9% UroLift™ PUL, 5.3% TURP, 5.3% GreenLight™ PVP, 6.2% Rezūm™ WVTT; rates are not statistically different). At five years, retreatment was lowest for TURP (7.0%) and statistically similar between GreenLight™ PVP and the UroLift™ System (8.9% and 11.6% respectively).* The retreatment rate for UroLift™ PUL (11.6%) is comparable to published controlled trial rates, thereby underscoring and demystifying the durability of the UroLift™ System.

“With this large-scale analysis, we aimed to provide a way for urologists and patients to understand retreatment for BPH therapies in a real-world setting,” said Steven Kaplan, MD, professor of Urology, Icahn School of Medicine at Mount Sinai, director of the Men’s Health Program at Mount Sinai Health System, New York, and lead author on the paper. “To my knowledge, it is the first time a uniform definition for retreatment has been applied to all the technologies. Perhaps what is most striking is the elevated rate of surgical retreatment occurring after TURP and GreenLight™ PVP within the first year.”

The study also provides a new way to assess and view complications following BPH surgery, defined as a “return procedure” in an outpatient setting. Under this definition, at one-year procedural complications were lowest following the UroLift™ System (15%) and highest following Rezūm™ WVTT (26%). The average time to the first complication was the longest for the UroLift™ PUL.

“This analysis helps urologists confidently counsel their patients about what to expect from different treatment options,” said Liam Kelly, Teleflex’s Chairman, President and Chief Executive Officer. “The UroLift™ System is the leading minimally invasive BPH treatment² precisely because it strikes a unique balance between durability and patient experience, and we’re thrilled to see that the UroLift™ System has the same low rates of complication and retreatment as what was demonstrated in our pivotal trial setting, providing patients with a superior experience to other minimally invasive treatments.”

The study will be featured and discussed by Dr. Kaplan in a 60-minute live webinar on November 30, 2023, hosted by Teleflex. Learn more and register here.

The study was supported by Teleflex Incorporated.

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 (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure,³ relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.^4-5 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**^6-7 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability.⁸ Most common side effects 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 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 450,000 men have been treated with the UroLift™ System in select markets worldwide.¹⁰ Learn more at www.UroLift.com. Rx only.

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 access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology 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™, QuikClot^™, Rüsch^™, UroLift^™ and Weck^™ – trusted brands united by a common sense of purpose. 

Forward-Looking Statements 
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. 

Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2023 Teleflex Incorporated. All rights reserved. MAC02799-01 Rev A

References: 

1. Kaplan, Prostate Cancer Prostatic Dis 2023
2. U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
3. Shore, Can J Urol 2014
4. Rukstalis, Prostate Cancer and Prostatic Dis 2018
5. UroLift System Instructions for Use 
6. AUA BPH Guidelines 2003, 2020 
7. McVary, Urology 2019
8. Roehrborn, Can J Urol 2017 
9. Roehrborn, J Urology 2013 
10. Management estimate based on product sales as of September 2023. Data on file Teleflex Interventional Urology. 

*Due to WVTT’s recent introduction, only a small number of patients with five-year data was available. As such, surgical retreatment rates were not extrapolated beyond one year. Doing so would have introduced sampling bias.

**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study 

Contacts: 
 
Teleflex Incorporated: 
Lawrence Keusch 
Vice President, Investor Relations and Strategy Development 
Investors.teleflex.com 
610-948-2836 

Media: 
Nicole Osmer 
nicole@healthandcommerce.com 
650-454-0504 

FAQ

What is the Nature journal Prostate Cancer and Prostatic Diseases study about?

The study reinforces the UroLift™ System as the gold standard in minimally invasive surgical treatment for benign prostatic hyperplasia.

What are the rates of surgical retreatment after BPH surgery?

Within one year of BPH surgery, 1 in 20 patients may require retreatment regardless of the treatment method.

Who is the lead author of the study?

Steven Kaplan, MD, professor of Urology, Icahn School of Medicine at Mount Sinai, director of the Men’s Health Program at Mount Sinai Health System, New York, and lead author on the paper.