Teleflex Incorporated (NYSE: TFX) today announced that data from
three studies of the UroLift® System were presented at the European
Association of Urology (EAU) 2020 virtual congress, underscoring
the safety and effectiveness of the minimally invasive treatment
for benign prostatic hyperplasia (BPH) among broad patient groups.
“The UroLift System is a standard of care treatment that
provides rapid symptom relief and recovery for patients suffering
from the burdensome symptoms of BPH,”1 said Dave Amerson, president
of Teleflex Interventional Urology business unit. “Results from
these studies are largely consistent with those found in previous
clinical studies of the UroLift System, further supporting the
safety and lasting benefits of this minimally invasive treatment in
the real-world and among difficult-to-treat patient
populations.”
Oliver Kayes, M.D.,* Leeds Teaching Hospitals NHS Trust,
presented Prostatic Urethral Lift Real-World Study Confirms
Effectiveness and Safety in a Broad Array of Patient Groups. The
study highlighted real-world results of 3,226 patients treated with
the UroLift System across 22 sites in the U.S., UK and Australia.
Outcomes were analyzed from patients with urinary retention, large
prostate volume (≥80g), obstructive median lobe (OML), and prior
radiation for prostate cancer, as well as non-urinary retention
patients, at one-month, three-month, six-month, one-year and
two-year timepoints.
Data from the study showed significant improvement in
International Prostate Symptom Score (IPSS) at all time points for
non-urinary retention patients following treatment with the UroLift
System and are generally consistent with randomized clinical
studies. Additionally, patients not seen typically in randomized
clinical studies, such as those with mild to moderate symptoms (n =
496), large prostate volume (n = 85), obstructive median lobes (n =
277) and those who received prior radiation for prostate cancer (n
= 82) experienced symptomatic improvement. Findings from the study
also showed that OML patients experienced significant relief after
treatment, with an average 46% improvement in IPSS at the
three-month timepoint.
“This is the largest and most comprehensive real-world
investigation of a minimally invasive treatment for enlarged
prostate, with results reaffirming those seen in controlled studies
of the UroLift System,” said Mr. Kayes. “Additionally, these data
indicate that the UroLift System provides rapid symptom relief to a
wide range of patient cohorts without affecting safety
outcomes.”
A presentation entitled 12-month symptom and urodynamic outcomes
of the prostatic urethral lift in patients with acute urinary
retention (PULSAR) was presented by Mark Rochester,* M.D., Norwich
& Norfolk University Hospital. The study examined the
feasibility of the UroLift System to treat patients with acute
urinary retention.
Results from the study showed that patients experienced symptom
relief at all time points following treatment with the UroLift
System. Absolute IPSS scores were consistent with the pivotal
L.I.F.T study, and quality of life outcomes were significantly
better at the six and 12-month timepoints following treatment. Of
the 52 patients included in the study, 60% were catheter-free by
one month, and 73% by six months through study end. Additionally,
82% of patients were able to stop treatment with alpha blockers
following treatment with the UroLift System and 87.5% of patients
returned to normal activities 8.5 days after treatment. Results
also demonstrated an improvement in urodynamic measurements among
patients treated with the UroLift System, with a 38% reduction in
Bladder Outlet Obstruction Index (BOOI). Finally, 83% of patients
reported that they would recommend the procedure.
“The results from this study contribute to the robust portfolio
of clinical evidence supporting the UroLift System treatment for
patient subgroups that are not commonly seen in clinical trials,”
said Mr. Rochester. “These findings highlight the safety and
effectiveness of the UroLift System in treating men with acute
urinary retention, offering this challenging patient population a
viable alternative to long-term catheter management and major
surgery.”
A third study — Meta-analysis comparison of sexual function
outcomes after treatment with prostatic urethral lift or medical
therapy — was presented by Claus Roehrborn,* M.D., University of
Texas Southwestern Medical Center. Results from the analysis showed
that patients treated with the UroLift System experienced
significant improvements in ejaculatory function and erectile
function through at least 24 months following treatment, while
patients in some medical therapy groups did not experience
significant average improvement at any timepoint.
“Data presented at the EAU meeting is an important reminder that
the UroLift System can be a solution for BPH patients and
urologists facing huge waiting lists driven by the pause in
elective surgeries due to COVID-19. Urologists can offer the
UroLift System in an outpatient setting, providing relief to their
patients without unnecessary delays,” said Matthew Wiggins, General
Manager, EMEA, Teleflex. “Furthermore, the data shows that the
UroLift System is an effective treatment for patients in urinary
retention, who, according to current EAU guidance in the COVID-19
era, should be prioritized due to their significant risks of
complications.”2
About the UroLift® SystemThe UroLift
System is a proven, minimally invasive technology for treating
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. 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.1,3,4 Most common adverse events are
temporary and can include hematuria, dysuria, micturition urgency,
pelvic pain, and urge incontinence.1 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
175,000 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 Teleflex Interventional UrologyThe
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.**5,6 Learn more at www.NeoTract.com.
About Teleflex IncorporatedTeleflex 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® and Weck® – trusted brands
united by a common sense of purpose.
*Mr. Oliver Kayes, Mr. Mark Rochester and Dr. Claus Roehrborn
are paid consultants of NeoTract | Teleflex Interventional
Urology.
Contacts:For Teleflex
Incorporated: Jake Elguicze, 610.948.2836 Treasurer and Vice
President, Investor Relations Media: Nicole Osmer, 650.454.0504
nicole@healthandcommerce.com
1 Roehrborn, J Urology 2013 LIFT Study2 European Association of
Urology. EAU Guidelines Office Rapid Reaction Group: An
organisation-wide collaborative effort to adapt the EAU guidelines
recommendations to the COVID era
https://uroweb.org/guideline/covid-19-recommendations/3 AUA BPH
Guidelines 2003, 2010, 20184 McVary, J Sex Med 2014 5 Shore, Can J
Urol 2014 Local Study6 Speakman et al. 2014 BJUI International** No
instances of new, sustained erectile or ejaculatory
dysfunction***Management estimate based on product sales and
average units per procedure
MAC01589-01 Rev A
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