Teleflex Incorporated (NYSE: TFX) today announced the presentation
of new clinical data at the American Urological Association (AUA)
2019 Annual Meeting from five studies of the UroLift® System
for patients with benign prostatic hyperplasia (BPH), showcasing
the safety and effectiveness of the minimally invasive treatment in
real-world patient populations.
“Findings from these studies are consistent with results found
in controlled clinical studies, reaffirming the safety and
long-term benefits of the minimally invasive UroLift System
treatment for BPH in diverse patient populations,” said Dave
Amerson, president of Teleflex Interventional Urology business
unit. “We are pleased to add this data to the growing portfolio of
real-world outcomes frequently found among more than one hundred
thousand patients that have been treated for BPH with the UroLift
System.”
Mark Rochester, M.D., Norwich & Norfolk University Hospital,
presented Early Outcomes of Prostate Urethral Lift in Subjects
Acute Urinary Retention. The study examined 52 patients to evaluate
the feasibility of the UroLift System treatment for patients with
acute urinary retention. The results demonstrated that 79% of
patients were catheter-free within three months, and 96% reported
being “much or very much better” at six months.
“Patients with acute urinary retention are faced with extremely
limited treatment options and have been previously excluded from
PUL studies,” said Dr. Rochester. “These results demonstrate that
the UroLift System treatment can quickly and safely restore urinary
flow in the majority of patients with acute urinary retention,
providing this challenging patient population a safe and effective
alternative to long-term catheter management and invasive BPH
treatment options.”
UroLift System Featured in Four Additional Presentations
at AUA Meeting
The presentation, Real World Outcomes of Prostatic Urethral Lift
Confirm Clinical Study Results, was presented by Steven Gange,
M.D., a urologist at Summit Urology Group in Salt Lake City. The
study highlighted real-world 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, despite the more diverse
patient population.
Gregory McMahon, D.O., urological surgery resident of Rowan
University of Osteopathic Medicine, Stratford, N.J., presented
Large Retrospectively Managed Single Surgeon Experience with
Prostatic Ureteral Lift, featuring the largest single surgeon
series reported on PUL. The study examined 156 patients that
received the UroLift System treatment from a single surgeon.
Results from the study shows statistically significant improvement
in BPH symptoms, quality of life and post-void residual volume for
patients treated with the UroLift System, and were similar to the
results reported from the pivotal L.I.F.T. study.
Prostatic Urethral Lift (PUL) Symptom and Sexual Function
Results Maintained in the Treatment of All Types of Prostate
Enlargement Including Obstructive Middle Lobe, was presented by
Daniel Rukstalis, M.D., professor of urology at Wake Forest School
of Medicine. The presentation featured results from the pivotal
randomized L.I.F.T. study combined with data from the MedLift Study
of the UroLift System for patients with an obstructive middle lobe
(OML). Findings from the study suggest that patients with all types
of prostate enlargement experience excellent symptom improvement
and preservation of sexual function.
Prostatic Urethral Lift (PUL) and Magnetic Resonance Imaging
(MRI): Defining artefact and risk of obscuring significant cancer
was presented by Peter Chin, M.B.B.S., associate professor at
Wollongong University Graduate School of Medicine in Australia. The
study examined 10 patients to define the size and location of
artefact caused by the UroLift System on MRI for patients
undergoing screening for prostate cancer. Results from the study
show the UroLift System is unlikely to obscure prostate cancer for
patients receiving MRI screening.
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 the U.S.,
Europe, Australia, Canada, Mexico and South Korea. 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 normal sexual
function. 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.
Dr. Peter Chin, Dr. Steven Gange, Dr. Mark Rochester, and Dr.
Daniel Rukstalis are paid consultants of Teleflex Incorporated.
Contacts:
For Teleflex Incorporated:Jake Elguicze, 610.948.2836Treasurer
and Vice President, Investor Relations
Media:Nicole Osmer, 650.454.0504nicole@healthandcommerce.com
*No instances of new, sustained erectile or ejaculatory
dysfunction 1. Roehrborn, J Urology 2013 LIFT Study 2. Shore, Can J
Urol 2014 Local Study
MAC01082-01 Rev A
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