NeoTract Announces FDA Clearance of Expanded Indications for UroLift® System
February 20 2018 - 5:30AM
Business Wire
Men with BPH with an Obstructive Median Lobe
and those age 45 Years Old or Older Now Also Eligible for
Treatment
NeoTract, a wholly owned subsidiary of Teleflex Incorporated
(NYSE: TFX) focused on addressing unmet needs in the field of
urology, today announced that the U.S. Food and Drug Administration
(FDA) has cleared new indications for the UroLift® System for the
treatment of enlarged prostate, or benign prostatic hyperplasia
(BPH). These expanded indications mean that patients who have an
obstructive median lobe and those as young as 45 are now eligible
to receive treatment with the UroLift System for their BPH
symptoms.
Previously, the UroLift System was contraindicated in patients
with an obstructive median lobe and only cleared for use in men 50
years of age or older. The MedLift study provided clinical evidence
to support the safe and effective treatment of obstructive median
lobes and to remove the contraindication.
“We are excited that more men with enlarged prostate are now
eligible for treatment with the UroLift System,” said Dave Amerson,
president, NeoTract | Teleflex Interventional Urology. “The
clinical data we have amassed on the UroLift System, including the
five-year data from the L.I.F.T. IDE study, has solidified the
product’s position as an important standard-of-care treatment for
men with BPH and is further bolstered by these expanded
indications. We are diligently training current UroLift users on
how to treat obstructive median lobes with the UroLift System so
they continue to see optimal patient outcomes.”
The treatment using the UroLift System has demonstrated that it
can get men off BPH medications and allow them to avoid major
surgery, while preserving sexual function. Results of the five-year
L.I.F.T. study demonstrate that the UroLift System treatment
provides a highly tolerable, minimally invasive procedural
experience, rapid reduction of symptoms after the procedure while
preserving sexual function, and sustained improvements in QoL
(Quality of Life) score, IPSS (International Prostate Symptom
Score), and Qmax (peak urinary flow rate). In addition, the
retreatment rate was just 2-3% per year, which compares well to the
1-2% expected rate for the gold standard TURP.1
Nearly 40 million men in the United States are affected by BPH,
which occurs with advancing age when the prostate gland that
surrounds the male urethra becomes enlarged and begins to obstruct
the urinary system. Symptoms of BPH often include interrupted sleep
and urinary problems, and can cause loss of productivity and
decreased quality of life.
Medication is often the first-line therapy for enlarged
prostate, but relief can be inadequate and temporary. Side effects
of medical therapy can include sexual dysfunction, dizziness and
headaches, prompting many patients to discontinue using drugs. For
these patients, the classic alternative is surgery that removes or
reduces the amount of prostate tissue to open the blocked urethra.
While current surgical options can be very effective in relieving
symptoms, they can also leave patients with permanent side effects
such as urinary incontinence, erectile dysfunction and retrograde
ejaculation (dry orgasm).
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 45,000 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.
1 Roehrborn et al. Can J Urol 2017
MAC00647-01 Rev A
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Teleflex IncorporatedJake Elguicze, 610-948-2836Treasurer and
Vice President, Investor RelationsorMedia Contact:Nicole Osmer,
650-454-0505nicole@healthandcommerce.com
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