New Data Reinforce Efficacy of the UroLift System for the Treatment of Enlarged Prostate

Teleflex

WAYNE, PA — Teleflex Incorporated (NYSE: TFX) announced the results of several recent research studies that further support the safety and efficacy of the UroLift® System for men living with enlarged prostate, or benign prostatic hyperplasia (BPH), including among those who have a wide range of prostate sizes and/or a median lobe obstruction. The data will be presented at the 37th Annual European Association of Urology (EAU) Congress in Amsterdam and virtually.

“Extensive research has shown that the UroLift System can consistently and rapidly improve BPH symptoms for our patients. The research conducted by some of the world’s foremost BPH experts and presented at this year’s EAU continues to build the body of support, which may help a broad population of men potentially avoid more invasive surgery,” said Jacqueline Welch, Vice President, Global Clinical and Scientific Operations, Teleflex.

Key findings include:

  • Pooled outcomes of over 300 controlled subjects from five clinical studies revealed most men shifted to lower international prostate symptom score (IPSS) symptom severity after treatment with Prostatic Urethral Lift (PUL).The majority of subjects (79%) improved by three points or more, and 66% of those patients moved into a lower IPSS severity grade 12 months post-treatment.1
  • Comparative evaluation of real-world and controlled trial outcomes of PUL demonstrated that symptom improvement is not correlated to prostate size and shape. The study examined PUL outcomes in differing gland sizes and morphologies, comparing controlled trial results from BPH6 for patients with small prostate sizes and MedLift for patients with obstructive median lobes. At 24 months, all groups demonstrated significant and sustained IPSS improvement.2,3,6
  • An analysis of U.S. healthcare claims revealed higher de novo prescription rates after transurethral resection of the prostate (TURP) and photoselective vaporization of the prostate (PVP) compared to PUL. The study revealed that post-surgical medication usage was significantly higher for BPH patients who were treated with more invasive surgical procedures as compared to those treated with the UroLift System.4
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“The UroLift System is the most well-studied minimally invasive surgical therapy for BPH. In a combined analysis from five controlled studies, we found that the majority of men who had received the procedure demonstrated measurable improvement in their BPH symptoms, flow rate, and quality of life. Subjects preserved their sexual function while some patients even experienced improvement in IIEF and MSHQ-EjD scores,” said Claus G. Roehrborn+, M.D., Urologist at the University of Texas Southwestern Medical Center and a lead author on the paper.*1,5

“The evidence presented at EAU means that urologists can further help their BPH patients make an objective, data-driven, and informed decision based on real-world evidence, particularly when faced with prostate sizes and shapes that fall outside of the range of randomized clinical trials. Our research showed not only rapid, but also durable improvement,” said Christian Gratzke+, Professor, Dr. Med. Medical Director, Urology Clinic, University Hospital, Freiburg.2

References:

  1. Roehrborn et al, EAU 2022. Pooled outcomes from five Prostatic Urethral Lift (PUL) controlled studies reveal most men can shift to lower IPSS symptom severity after treatment. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
  2. Gratzke et al, EAU 2022. Prostatic Urethral Lift (PUL) outcomes are independent of prostate size and shape in real-world and controlled trial settings, EAU 2022. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
  3. Sonksen et al. Eur Urol 2015
  4. Kaplan et al. EAU 2022. De Novo BPH Prescription Rates are Higher after TURP and PVP compared to PUL: a US Healthcare Claims Analysis. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
  5. Roehrborn, C.G., and Rukstalis, D.B., Eur UrolFocus 2021
  6. Rukstalis, Prostate Cancer and Prostatic Dis 2018
  7. Roehrborn, Can J Urol 2017
  8. AUA BPH Guidelines 2003, 2020
  9. McVary, J Sex Med 2016
  10. Roehrborn, J Urology 2013
  11. Management estimate based on product sales as of April 2022. Data on file with Teleflex
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