Will expand patient access to breakthrough BPH treatment
WAYNE, Pa. – December 13, 2021 – Teleflex Incorporated (NYSE: TFX) today announced that the company has received reimbursement approval from the Central Social Insurance Medical Council of Japan (Chuikyo) of its UroLift System for patients who require treatment for benign prostatic hyperplasia (BPH).
The UroLift System treatment is a minimally invasive approach to treating BPH, commonly known as an enlarged prostate, a condition that causes bothersome urinary symptoms in men. Performed as a same-day outpatient procedure,1 the UroLift System can help improve quality of life,2 and offers lasting relief from symptoms with minimal downtime for patients.1,3
Liam Kelly, Chairman, President and Chief Executive Officer said, “I am proud of how the team has achieved reimbursement approval for the UroLift System in Japan. We have strategically directed investment into developing our UroLift commercial and clinical capabilities in Japan and will be in a position to perform our first training cases in the first quarter of 2022. We are excited to bring this clinically beneficial treatment to the more than two million men suffering from BPH in Japan.4”
“The UroLift System is a major advancement in the treatment of BPH and can positively impact patients’ quality of life. We are very excited to have this technology available soon in Japan and look forward to its use in treating our patients,” said Satoru Takahashi, Professor and Chairman, Department of Urology, Nihon University School of Medicine.*
The newly approved reimbursement for the UroLift System in Japan goes into effect April 1, 2022. Teleflex currently plans to enroll a PMDA-mandated, post-market clinical study to expand its already robust clinical data on the efficacy of the UroLift System and support widespread adoption of the UroLift System in Japan.
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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 of, or removing prostate tissue. The UroLift System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.5 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**2,6,7 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.3 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 300,000 men have been treated with the UroLift System in select markets worldwide.8 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 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.
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.**2,6,7 Learn more at Urolift.com
Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® — trusted brands united by a common sense of purpose.
For Teleflex Incorporated:
Vice President, Investor Relations and Strategy Development
John Hsu, CFA
Vice President, Investor Relations
*Previously a paid consultant of Teleflex Incorporated or its affiliates.
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.
1. Shore, Can J Urol 2014
2. Roehrborn, Can J Urol 2017
3. Roehrborn, J Urology 2013
4. Management market estimates for Japan 2021, data on file
5. Rukstalis, Prostate Cancer and Prostatic Dis 2018
6. AUA BPH Guidelines 2003, 2020
7. McVary, J Sex Med 2016
8. Management estimate based on product sales and average units per procedure
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.
© 2021 Teleflex Incorporated. All rights reserved
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