Retrospective Study of Data from More than 800
Patients Consistent with Published, Controlled Clinical Studies
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):
- 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
- 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
- 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 study2
Roehrborn et al. Can J Urol 2017 MAC00681-01 Rev A
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