Teleflex Announces FDA Clearance for Expanded Indication of the UroLift® System for Treatment of Larger Prostates, Up to 100...
January 07 2020 - 6:30AM
Teleflex Incorporated (NYSE: TFX) today announced that the U.S.
Food and Drug Administration (FDA) has granted the company an
expanded indication for the use of its UroLift® System to treat
larger prostates, between 80cc and100cc. This minimally invasive,
in-office treatment provides rapid relief and recovery from the
symptoms of benign prostatic hyperplasia (BPH).1,2
BPH, also known as enlarged prostate, is
non-cancerous enlargement of the prostate that occurs as men age.
The condition affects over 40 million men in the United States
alone.3 More than 40% of men in their 50s have BPH and over 80% of
men in their 70s have BPH. The symptoms of BPH can include frequent
urination and can cause loss of productivity, depression and
decreased quality of life.4 If left untreated, the condition can
worsen over time and cause permanent bladder damage.5
“This new indication marks another exciting
milestone for Teleflex and an opportunity for hundreds of thousands
more men to benefit from the UroLift System and the durable and
lasting relief it can provide from burdensome BPH symptoms,” said
Dave Amerson, president of the Teleflex Interventional Urology
business unit. “Over 100,000 men have been treated with the UroLift
System worldwide and now many more will be candidates for this
proven approach to treating enlarged prostate that may enable men
to get off BPH medications and avoid major surgery.”
The collection of data presented to the FDA
demonstrates that the UroLift System treatment is safe and
effective in men with prostate sizes between 80cc and 100cc, with
outcomes similar to the L.I.F.T. randomized controlled trial.1
Further, there are no discernable differences in reported adverse
events, indicating a comparable safety profile.
There is also a strong and growing body of clinical
evidence supporting the safe, effective use of the UroLift System,
including a large retrospective real-world study which highlights
the results of 1,413 patients who received the UroLift System
treatment across 14 sites in North America and Australia. Results
were consistent with those seen in previous clinical studies of the
UroLift System treatment, and included patient subgroups—such as
those in retention, with large prostates and comorbidities such as
diabetes and prostate cancer—not commonly seen in clinical
trials.
“We have learned from the Real-World study and
other clinical studies that the UroLift System is the only
minimally invasive treatment option that delivers rapid relief and
recovery in days not months1,” said Thomas J. Mueller**, M.D., New
Jersey Urology. “I am pleased that this indication will enable even
more men to benefit from this groundbreaking technology.”
About the UroLift® SystemThe
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.*1,[2]
Patients also experienced significant improvement in quality of
life. Over 100,000 men have been treated with the UroLift System
worldwide. 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 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. The UroLift System is
available in many markets worldwide. 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 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 sexual function.*2,4 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.
**Thomas J. Mueller, M.D., is a paid consultant of
NeoTract | Teleflex Interventional Urology.
Contacts:
For Teleflex Incorporated:Jake Elguicze,
610.948.2836Treasurer and Vice President, Investor Relations
Media:Nicole Osmer,
650.454.0504nicole@healthandcommerce.com
_______________________________
1. Roehrborn, J Urology 2013 LIFT Study2. Shore, Can J Urol 2014
Local Study3. NeoTract US Market Model estimates for 2018 based on
IQVIA Health Drug and Procedure data4. Speakman et al. 2014 BJUI
International 5. Tubaro et al. 2003 Drugs Aging *No
instances of new, sustained erectile or ejaculatory dysfunction
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