New Data Highlight that Early Intervention with the UroLift® System Facilitates Long-Term Outcomes for BPH Patients

WAYNE, Pa., May 03, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced new research findings reinforcing the long-term durability of Prostatic Urethral Lift (PUL) with the UroLift^® System and lower complication rates compared to other minimally invasive procedures for men with enlarged prostate, also called benign prostatic hyperplasia (BPH).^1-3 Results were presented at the Annual Meeting of the American Urological Association in Chicago, April 28–May 1, 2023. The UroLift^® System is the number one minimally invasive BPH procedure chosen by urologists and their patients in the U.S.⁴

“Arriving at the intersection of effective BPH treatment, patient priorities and available technology can be a daunting task,” said Mr. Olly Kayes, MD, Honorary Senior Lecturer at the University of Leeds and primary investigator of the PULSAR study. “These new analyses show that the UroLift^® System offers unique benefits for many men searching for long-term relief of burdensome symptoms affecting their quality of life. The UroLift^® System can be an excellent option for patients seeking quick and durable symptom improvement with preservation of sexual function and low risk of serious complications.”

Key findings from the studies presented are:

Early treatment prior to severe symptoms positively impacts long-term durability¹

• Pooled outcomes in more than 330 UroLift^® System subjects treated in a controlled setting were analyzed and reported by Claus Roehrborn et. al.
• PUL with the UroLift^® System was durable in most subjects at one and five years. 13.7% of subjects needed surgical retreatment at 5 years, which is highly consistent with the five-year surgical retreatment rates reported in the L.I.F.T. study (13.6%).
• Treatment earlier in the disease continuum, indicated by factors such as better overall International Prostate Symptom Score (IPSS) and quality of life (QoL) scores at baseline, facilitates long-term durability.
  

The largest healthcare utilization study for BPH therapies continues to show that the UroLift^® System has the lowest complication rate, and medical therapy is not without consequences²

• Steve Kaplan et. al. analyzed patient-level data on over 200,000 men with BPH who received medical therapy only (α-blockers, 5-ARIs, anti-cholinergics, β3-agonists, PDE5-inhibitors); MIST (PUL with UroLift^® System, Rezūm™ water vapor therapy); or invasive surgery (TURP, photoselective vaporization of the prostate (PVP), Aquablation^®) in an outpatient setting from 2015–2021.

• Approximately 6% of over 200,000 medical therapy patients in this study underwent BPH-related procedures, including cystoscopy, catheterization and bladder irrigation through one year as the disease progressed. Top diagnoses that drove cystoscopies included lower urinary tract symptoms (LUTS) and urinary retention.
  
• In surgical therapy patients, procedure complication rates were lowest for the UroLift^® System (17%) and highest for Rezūm™ (28%). Procedural complication rates were similar between TURP, PVP and Aquablation^® (~22%, 21% and 20% respectively).
  

Earlier intervention in patients with urinary retention increases the likelihood of becoming catheter-independent after treatment³

• The PULSAR study (n=51), reported by Olly Kayes et. al., prospectively examined 12-month outcomes of the UroLift^® System treatment in subjects with urinary retention. Results were compared to 388 retention patients in the real-world retrospective study.
• After treatment with the UroLift^® System, 73% of controlled study subjects and 80% of real-world study subjects were catheter- and surgery-free at 12 months; success was associated with higher voiding efficiency during the perioperative period.
• Variables that influenced success included age under 70 years at procedure, lower baseline prostate-specific antigen (PSA) and post-void residual (PVR) levels, and shorter pre-procedural catheter duration.
• These data may help providers to better understand results after the UroLift^® System procedure and enable more men in urinary retention to obtain safe and effective BPH treatment.

“We are in the midst of a paradigm shift in the BPH landscape,” said Kevin Hardage, President and General Manager of Teleflex Interventional Urology. “As clinicians listen to their patients’ goals, technological advances are allowing them to deliver treatments that reflect those priorities better than ever before. The data presented at AUA reinforce the importance of earlier intervention in BPH and the UroLift^® System as an effective and durable BPH solution that improves patients’ quality of life and supports a superior patient experience.”^1-3

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^® permanent implants, which can be delivered during an outpatient procedure,⁵ 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.⁶ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**^7-9 The 5-year L.I.F.T. study results demonstrate UroLift^® System durability with a surgical retreatment rate of about 2-3% per year and 13.6% total over 5 years.⁷ Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.¹⁰ 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. More than 425,000 men have been treated with the UroLift^® System in select markets worldwide.¹¹ Learn more at 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.

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.

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

*Drs. Olly Kayes and Claus Roehrborn are paid consultants of Teleflex.

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

References:

1. Roehrborn, et al, AUA 2023. Durability following treatment with the Prostatic Urethral Lift (PUL): Predictors from over 330 controlled subjects across 5 distinct studies. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
2. Kaplan, et al, EAU 2023. The Impact of BPH Care: Procedural Complications Associated with MIST and Traditional Surgery Compared to Disease Progression with Medical Therapy. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
3. Kayes, et al, AUA 2023. Successful Outcomes in Acute Urinary Retention (AUR) Patients Treated with the Prostatic Urethral Lift (PUL) are Associated with Earlier Intervention. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
4. 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
5. Shore, Can J Urol 2014
6. Rukstalis, Prostate Cancer and Prostatic Dis 2018
7. Roehrborn, Can J Urol 2017
8. AUA BPH Guidelines 2003, 2020
9. McVary, Urology 2019
10. Roehrborn, J Urology 2013
11. Management estimate based on product sales as of April 2023. Data on file Teleflex Interventional Urology.
    

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