Teleflex Announces Large-Scale Analysis of Real-World Healthcare Claims Data for Enlarged Prostate Procedures at the American Urological Association 2021 Annual Meeting

Late-Breaking Data Presentation Reveals How UroLift PUL’s Post-Operative Events Compare With Other Minimally Invasive Procedures and Traditional Surgery for the Treatment of BPH

WAYNE, Pa., Sept. 14, 2021 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE:TFX) today announced that new real-world healthcare claims data reveal that the risk of return procedures is lowest after treatment with the UroLift® System among the analyzed benign prostatic hyperplasia (BPH) treatment options. The data also show that the risk of surgical retreatment is similar between UroLift PUL, TURP and GreenLight™ PVP while highest following Rezūm™ Water Vapor Therapy. The study “UroLift PUL Compared to Rezūm, TURP and GreenLight PVP: Results From an Analysis of U.S. Medicare and Commercial Claims,” which was sponsored by Teleflex, was presented Sunday, September 12 by Steven Kaplan+, M.D., of Mount Sinai, New York City, at the virtual American Urological Association (AUA) 2021 Annual Meeting.

“It is important for urologists to have access to well-designed, large-scale, real-world comparative data for surgical and minimally invasive BPH treatments. Until now, comprehensive healthcare utilization data that includes surgical retreatment rates have been missing from the urologist toolbox when discussing these important factors surrounding treatment options with their BPH patients,” said Dr. Kaplan, lead author. “This study revealed real-world surgical retreatment rates that are comparable among the UroLift System, TURP and GreenLight while highest for Rezūm.”

The study analyzed a representative sample of U.S. Medicare and commercial claims from IBM Watson among men with a BPH diagnosis who received therapy for the condition in an outpatient setting from 2015 through 2019. The database included 5,228 UroLift System prostatic urethral lift (PUL) patients; 19,507 transurethral resection of the prostate (TURP) patients; 10,173 GreenLight patients; and 935 Rezūm** patients.

The research defines differences between return procedures (post-operative procedure performed during a return visit to an outpatient setting identified by a CPT or ICD 9/10 code), and surgical retreatment [secondary BPH procedure (Rezūm, GreenLight, transurethral resection of the prostate (TURP), prostatic urethral lift (PUL) or holmium laser enucleation of the prostate (HoLEP)] occurring after the original index. The analysis utilized a Cox proportional hazard model to account and adjust for variables which may have differed between treatment populations, such as age, cost of index procedure, comorbidities, adverse events, and site of service.

Results from the analysis showed:

  • Post-treatment return procedure rates at the 365-day mark were lowest (17%) with UroLift PUL patients and highest (23%) among Rezūm patients (UroLift PUL vs Rezūm: p<0.0001).
  • Adjusting for available population variables using hazard modeling, UroLift PUL was associated with a lower risk of undergoing a return procedure compared to GreenLight, Rezūm, and TURP:
    • 24% higher TURP vs PUL (p<0.0001)
    • 35% higher GreenLight vs PUL (p<0.0001)
    • 41% higher Rezūm vs PUL (p<0.0001)
  • Surgical retreatment rates at the 365-day mark were similar between GreenLight (5.2%), TURP (5.3%), and PUL (5.4%). The rate of surgical retreatment for Rezūm (7.2%) was higher compared to UroLift PUL (p=0.04).
  • When assessing risk at 365 days via hazard modeling, there was a similar risk of surgical retreatment associated with GreenLight, TURP, and UroLift PUL. Rezūm was associated with a higher risk of surgical retreatment:
    • 36% higher Rezūm vs PUL (p=0.03)
    • 40% higher Rezūm vs TURP (p=0.01)
    • 43% higher Rezūm vs GreenLight (p=0.009)

“Surgical retreatment is an important factor for urologists and their patients to consider when evaluating BPH therapies. By performing a large-scale observational analysis of Medicare and commercial claims, we were able to see how the UroLift System and other BPH therapies perform in the real-world post-treatment,” said Kevin Hardage, President of the Teleflex Interventional Urology business unit. “In the analysis, the UroLift System had the lowest rate of return procedures and similar surgical retreatment rates as GreenLight and TURP. The results from the analysis support the UroLift System as an optimal course of treatment for many men diagnosed with BPH.”

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 100 cc in men 45 years or older (50 years outside U.S.). 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.*1-3 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.1 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 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.*1-3 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.

Contacts:
Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

John Hsu, CFA
Vice President, Investor Relations
investors.teleflex.com
610.948.2836

Media:
Nicole Osmer, 650.454.0504
[email protected]

**CPT/HCPCS codes: 53899 (2015-2018); 53854/C9748 (2019). Rezūm was granted their specific CPT/HCPCS codes in 2019 but were operating under the CPT code 53899 prior to 2019.

Management estimate based on product sales and average units per procedure.
+ Steven A. Kaplan, M.D., is the lead author of the Healthcare Claims and Utilization Analysis and not a paid consultant for NeoTract | Teleflex.

References
* No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.
1. Roehrborn, J Urology 2013 LIFT Study
2. AUA BPH Guidelines 2003, 2020
3. McVary, J Sex Med 2016

Teleflex, the Teleflex logo, NeoTract, the NeoTract logo and UroLift are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
Rezum™ and GreenLight™ are trademarks of Boston Scientific Corporation or its affiliates.

Certain data used in this study were supplied by International Business Machines Corporation as part of one or more IBM MarketScan Research Databases. Any analysis, interpretation, or conclusion based on these data is solely that of the authors and not International Business Machines Corporation.

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