Retrospective Study of Data from More than 800 Patients Consistent
with Published, Controlled Clinical Studies
WAYNE, Pa.--(BUSINESS WIRE)--Mar. 19, 2018--
NeoTract, a wholly owned subsidiary of Teleflex Incorporated
(NYSE:TFX) focused on addressing unmet needs in the field of urology,
today announced the results from the first analysis of a retrospective
registry of more than 800 UroLift® System procedures
performed at seven centers in North America, Europe and Australia.
The study, which was presented by Oliver Kayes, M.D., of Leeds Teaching
Hospital in Leeds, U.K., found that the UroLift System offers
significant improvement in symptoms and quality of life through 24
months among patients in the “real world” (non-clinical trial setting):
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With a 40% reduction in IPSS score at 24 months, results were
consistent with the data from the randomized, five-year L.I.F.T.
study. L.I.F.T. demonstrated that the UroLift System treatment
provides a highly tolerable minimally invasive procedural experience,
rapid reduction of symptoms after the procedure, and sustained
improvements in QoL (Quality of Life) score, IPSS (International
Prostate Symptom Score), and Qmax (peak urinary flow rate), while
preserving sexual function.1
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The registry retreatment rate was consistent with L.I.F.T., which
demonstrated a retreatment rate of just 2-3% per year, comparing well
to the 1-2% expected rate for the gold standard TURP.2
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Additionally, the registry included patients in urinary retention
prior to treatment. Of those with follow up data, 96% were able to
urinate without use of a catheter within the first month.
The registry will continue to enroll additional sites and is expected to
increase to more than 2,000 patients.
“The findings of this large multi-center, multi-national retrospective
study of results from hundreds of men should give urologists and
patients confidence that the outcomes for UroLift System in published,
controlled clinical studies are representative of real-world usage,”
said Mr. Kayes, who presented the results at the European Association of
Urology annual meeting in Copenhagen. “The data strongly supports the
UroLift System as a compelling rapid, minimally invasive option for BPH
that offers symptom relief with minimal side effects and does not cause
sexual dysfunction.”
“With this data, the UroLift System continues to prove itself as the new
standard of care for men with enlarged prostate,” said Dave Amerson,
president of the NeoTract Interventional Urology business unit.
“Clinical adoption of the UroLift System procedure continues to grow
rapidly worldwide. We are gratified to know this means that tens of
thousands of men are now living better lives, relieved of the symptoms
of BPH.”
Recently the U.S. Food and Drug Administration (FDA) cleared new
indications for the UroLift System, making patients who have an
obstructive median lobe and those as young as 45 now eligible to receive
treatment with the UroLift System for their BPH symptoms.
Benign prostatic hyperplasia (BPH), also known as enlarged prostate, is
non-cancerous enlargement of the prostate that occurs as men age. The
condition, which affects more than 40% of men over 50 and over 70% of
men in their 60s, is marked by bothersome urinary symptoms that can
cause loss of productivity, depression, interrupted sleep, and decreased
quality of life.
BPH is not a pre-cursor to prostate cancer, but is twelve times more
common, especially as men age. Over 40 percent of men in their 50s have
BPH and over 70 percent of men in their 60s have the condition. The
incidence rate climbs to 80 percent for men over the age of 70. If BPH
is left untreated, the condition can worsen over time and cause
permanent bladder damage.
Medication is often the first-line therapy for enlarged prostate, but
relief can be inadequate and temporary. Side effects of medication
treatment can include sexual dysfunction, dizziness and headaches,
prompting many patients to quit using the drugs. For these patients, the
classic alternative is surgery that cuts, heats or removes prostate
tissue to open the blocked urethra.
About the UroLift System
The FDA-cleared UroLift System is a proven, minimally invasive
technology for treating lower urinary tract symptoms due to benign
prostatic hyperplasia (BPH). The UroLift permanent implants, delivered
during a minimally invasive transurethral outpatient procedure, relieve
prostate obstruction and open the urethra directly without cutting,
heating, or removing prostate tissue. Clinical data from a pivotal
206-patient randomized controlled study showed that patients with
enlarged prostate receiving UroLift implants reported rapid and durable
symptomatic and urinary flow rate improvement without compromising
sexual function. Patients also experienced a significant improvement in
quality of life. More than 50,000 men worldwide have been treated with
the UroLift System. Most common adverse events reported include
hematuria, dysuria, micturition urgency, pelvic pain, and urge
incontinence. Most symptoms were mild to moderate in severity and
resolved within two to four weeks after the procedure. The UroLift
System is available in the U.S., Europe, Australia, Canada, Mexico and
South Korea. 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®
and Weck® – trusted brands united by a common sense of
purpose.
Oliver Kayes is a paid consultant to NeoTract | Teleflex Interventional
Urology.
1 No instances of de novo (or new), sustained erectile or
ejaculatory dysfunction. Roehrborn, J Urology 2013 LIFT Study;
Roehrborn, 2015 Can J Urol, 3 yr results of PUL LIFT study
2
Roehrborn et al. Can J Urol 2017 MAC00681-01 Rev A
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