New Data Highlight that Early Intervention with the UroLift® System Facilitates Long-Term Outcomes for BPH Patients
03 Maio 2023 - 7:30AM
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
KeuschVice President, Investor Relations and Strategy
DevelopmentInvestors.teleflex.com610-948-2836Media:Nicole
Osmernicole@healthandcommerce.com650-454-0504*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:
- 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
- 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
- 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
- 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
- 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 April 2023. 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. MAC02685-01 Rev A
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