UroLift® System Research Data from EAU Highlight Durability and Superior Patient Experience, Along with Benefits of Earlier Treatment for BPH
March 13 2023 - 6:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced new research from controlled
and real-world studies of the Prostatic Urethral Lift (PUL)
procedure with the UroLift® System, for treating men with benign
prostatic hyperplasia (BPH). Results underscore the benefits of
early intervention with respect to durability, symptom improvement
and sexual function that urologists around the world have come to
expect from the UroLift® System, which is the leading minimally
invasive, outpatient treatment in the United States for enlarged
prostate.1 The research was presented at the 38th Annual European
Association of Urology (EAU) Congress taking place in Milan from
March 10-13, 2023.
“These important new analyses show that, whether
compared to other interventions or medication, the UroLift® System
offers unique benefits that make it the treatment of choice for
many men searching for long-term relief of burdensome BPH
symptoms,” said Jacqueline Welch, Vice President, Global Clinical
and Scientific Operations, Teleflex.
Following are key findings from the studies:
Results from over 330 PUL subjects studied in a
controlled
setting2,3
- PUL with the UroLift® System was durable in most subjects at
one and five years. Lower durability at one year is associated with
undertreatment (≤4 implants placed).2 Lower durability at five
years is affected by poor baseline obstructive symptoms indicated
by the International Prostate Symptom Score (IPSS).2
- Earlier treatment in the disease continuum (i.e., better IPSS
and quality of life (QoL) scores at baseline) positively impacts
quality of life outcomes. Similarly, treatment with the UroLift®
System prior to severe erectile dysfunction in sexually active
patients predicts the likelihood of a patient achieving meaningful
change in the Sexual Health Inventory for Men (SHIM)
assessment.3
Comprehensive patient experience results of obstructive
median lobe (OML) subjects treated with
PUL4
- In responder analysis utilizing the novel BPH6 study endpoints
(relief of symptoms, quality of recovery, preservation of sexual
function, preservation of continence and safety),** UroLift® System
OML and lateral lobe patients responded consistently.4
- Compared to Transurethral Resection of the Prostate (TURP) done
in lateral lobes, UroLift® System OML subjects achieved superior
quality of recovery and preservation of ejaculatory function.
Additionally, only these TURP subjects experienced high-severity
adverse events.4
Outcomes from the largest healthcare utilization study
for BPH therapies, including
medication5
- Approximately 6% of medical therapy patients
underwent BPH-related procedures through 1 year as the disease
progressed.5
- Procedure complication rates were similar between TURP,
Photoselective Vaporization of the Prostate (PVP) and Aquablation®,
and lowest for PUL with the UroLift® System. Although the
Aquablation® data were relatively immature because of the newness
of the technology, the complication rate (~20%) indicates a safety
profile similar to more invasive treatments.5
“The research presented at EAU reinforces the
UroLift® System as an effective and durable BPH solution, backed by
meaningful quality of life data that support a superior patient
experience,” said Steven Gange, M.D., F.A.C.S., of Summit Urology
Group and Associate Medical Director of the Teleflex Interventional
Urology Business Unit. “The results from these studies emphasize
the value of the UroLift® System in successfully treating BPH
symptoms, enabling rapid recovery, preserving sexual function, and
improving patients’ overall quality of life.”2-5
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,6 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.7 It is
the only leading BPH procedure shown to not cause new onset,
sustained erectile or ejaculatory dysfunction.*8-10 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.8 Most common side effects are temporary and can
include hematuria, dysuria, micturition urgency, pelvic pain, and
urge incontinence.11 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 400,000 men have been treated with the UroLift® System in
select markets worldwide.12 Learn more at www.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 KeuschVice
President, Investor Relations and Strategy
DevelopmentInvestors.teleflex.com610-948-2836
Media:Nicole
Osmernicole@healthandcommerce.com 650-454-0504
*No instances of new, sustained erectile or ejaculatory
dysfunction in the L.I.F.T. pivotal study
** Individual elements of the BPH6 composite endpoint assessed
the following: 1) LUTS improvement; 2) Quality of Recovery; 3)
Preservation of Erectile function, 4) Preservation of Ejaculatory
function; 5) Continence preservation; and 6) Safety
References:
- 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
- Roehrborn, et al, EAU 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
- Barber, et al, EAU 2023. Patient characteristics and dynamic
variables predictive of meaningful quality of life and sexual
function improvement after Prostatic Urethral Lift (PUL).
[Conference Presentation] Study sponsored by Teleflex Incorporated
or its affiliates
- Eure, et al, EAU 2023. Patient experience outcomes are
consistent between men with median and lateral lobe obstruction
following treatment with the Prostatic Urethral Lift (PUL).
[Conference Presentation] Study sponsored by Teleflex Incorporated
or its affiliates
- 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
- Shore, Can J Urol 2014
- Rukstalis, Prostate Cancer and Prostatic Dis 2018
- Roehrborn, Can J Urol 2017
- AUA BPH Guidelines 2003, 2020
- McVary, Urology 2019
- Roehrborn, J Urology 2013
- Management estimate based on product sales as of December 2022.
Data on file Teleflex Interventional Urology.
Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®,
QuikClot®, Rüsch®, UroLift®, and Weck® – trusted brands united by a
common sense of purpose.
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. All other trademarks are the property of
their respective owners.
© 2023 Teleflex Incorporated. All rights reserved. MAC02656-01
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