PA-TELEFLEX
11.3.2021 08:02:06 CET | Business Wire | Press release
Teleflex Incorporated (NYSE: TFX)– Men in France living with Benign Prostatic Hyperplasia (BPH), a condition in which the prostate enlarges as men get older and can cause significant discomfort, will now be offered a newly available minimally invasive treatment on the public health care system, the UroLift® System. The proven procedure, developed by medical technology provider Teleflex to treat lower urinary tract symptoms due to BPH, is now reimbursable under French mandatory health insurance for the first time.
Following a positive Haute Autorité de Santé (HAS) assessment, a procedure code has been granted allowing hospitals to offer the UroLift System to men over 50 years of age who show symptoms of an enlarged prostate up to 100cc. † Approximately 250,000 people have already been treated with the device worldwide* and it is estimated that, in France, between 3,400 and 6,900 patients could benefit from the procedure each year.1
Unlike more invasive surgical treatments and prescription medicines which can lead to erectile or ejaculatory dysfunction, the UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction, while being safe and effective.2,3,4, It has demonstrated a more positive impact on quality of life than reported for patients on pharmaceutical medications. 2,3
In those living with BPH, the prostate can press on and block the urethra, potentially causing an urgent need to urinate, and a need to urinate frequently, among other symptoms. It is estimated that almost two million men live with the condition in France.5 The UroLift permanent implants, delivered during an outpatient procedure, can relieve prostate obstruction without cutting, heating, or removing prostate tissue. Patients typically can return home the same day without a catheter and experience rapid symptom relief and recovery with low complication rates.6,7
Matt Wiggins, Interventional Urology General Manager, EMEA, said: “Today’s decision means men in France finally have a safe and effective treatment option which does not compromise on sexual function.**2 As patients can be treated with the UroLift System in an ambulatory setting, rather than a classical operating theatre, and allows patients to be discharged quickly, usually without a catheter, it gives French urologists a new way to relieve some of the pressure on resources caused by the COVID-19 pandemic and pause on elective surgeries.6,7 The UroLift System has the potential to save hours of theatre time and bed days, while reducing complications and waiting lists, making it a timely alternative for those wishing to ease the strain on current services.8,9 ”
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 50 years or older. As with any medical procedure, individual results may vary. The UroLift permanent implants, delivered during an outpatient procedure, relieve prostate obstruction without cutting, heating, or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction in the L.I.F.T pivotal study.1 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. Consult the Instructions for Use (IFU) for more information. 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. Approximately 200,000 men have been treated with the UroLift System in select markets worldwide.* As with any medical procedure, individual results may vary. Learn more at www.UroLift.com .
About NeoTract | Teleflex Interventional Urology
A wholly owned subsidiary of Teleflex Incorporated, the NeoTract 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 initial 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 normal sexual function. Learn more at www.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 www.teleflex.com .
Teleflex is the home of Arrow® , Deknatel® , Hudson RCI® , LMA® , Pilling® , Rusch® , UroLift® System and Weck® – trusted brands united by a common sense of purpose.
MAC01749-02 Rev A:
* Management estimate based on product sales and average units per procedure
** No instances of new onset, sustained erectile or ejaculatory dysfunction in the L.I.F.T pivotal study
† Contraindications: The UroLift System should not be used if the patient has; a prostate volume >100cc, a urinary tract infection
1. https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-6011_UROLIFT_05_novembre_2019_(6011)_avis.pdf
2. Roehrborn et al. Can J Urol 2017
3. AUA Guidelines 2003
4. McVary, J Sex Med 2014
5. NeoTract OUS Market Model estimates for 2021
6. Shore, Can J Urol 2014
7. Roehrborn, J Urology 2013
8. Orlowski ISPOR 2018
9. NICE Shared Learning Case Study – UroLift Norfolk and Norwich NHS Trust. 2016
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