Early Results Reported to Be Better Than Pivotal Trial Data at
Experienced Center
WAYNE, Pa.--(BUSINESS WIRE)--Oct. 15, 2018--
NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX)
focused on addressing unmet needs in the field of urology, today
announced the presentation of new clinical data at the 2018 Annual
Meeting of the Northeastern Section of the American Urology Association
(AUA) in Toronto, Ontario, from a study of the company’s novel UroLift®
System for patients with Benign Prostatic Hyperplasia (BPH).
The real-world study, which enrolled 100 patients at a single center,
evaluated the UroLift System treatment for lower urinary tract symptoms
(LUTS) in men with BPH. The study, presented by Bashar Omarbasha, M.D.,
chief of urology at Oneida Healthcare and Rome Memorial Hospital in
Oneida, New York, analyzed outcomes from patients to examine how the
UroLift System performs in a real-world setting and whether outcomes are
similar to those seen in clinical studies.
Data from the study showed a 62% improvement in International Prostate
Symptom Score (IPSS) two months after treatment. Peak flow rate improved
140% and the post-void residual volume (PVR) decreased by 71 ml, with no
patients requiring re-operation. These changes are statistically better
than the pivotal L.I.F.T trial results.
“Clinical data from previous studies have proven that the UroLift System
offers rapid and durable relief of symptoms and improved quality of life
for patients with BPH,” said Dr. Omarbasha. “The results of this study,
from my first 100 UroLift System patients, are even better than the
pivotal L.I.F.T clinical study at the three-month follow up timepoint,
adding to the clinical evidence that shows the UroLift System can be
used in the real world safely and effectively.”
Several recent single-center studies have established that results from
the L.I.F.T clinical study are being replicated by investigators in the
real world. Results from the Real-World Experience Study, presented at
the World Congress of Endourology 2018 Annual Conference by Mark
Rochester, M.D., consultant urological surgeon of Norfolk and Norwich
University Hospitals NHS Foundation Trust U.K., were consistent with the
pivotal L.I.F.T study, showing improvement of IPSS, peak flow rate, and
quality of life in patients treated for BPH with the UroLift System in a
real-world setting.
Data presented at the 2018 Annual Meeting of the New England Section of
the AUA by Campbell F. Bryson, M.D., chief urology resident of Yale New
Haven Hospital in Princeton, N.J., from a single-center, first-time
study closely resembles results from the pivotal L.I.F.T trial, showing
robust improvements in symptoms and quality of life for patients with
BPH who received the UroLift System treatment in a real-world setting.
“The results of these numerous real-world studies help to further
validate the many advantages of the UroLift System for patients with BPH
in the real world,” said Dave Amerson, president of the Teleflex
Interventional Urology business unit. “We are proud to be improving the
lives of patients suffering with the symptoms of BPH by providing a safe
and effective treatment that provides rapid relief and allows men to
stop or reduce BPH medications, without compromising sexual function.”
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. Nearly 70,000 men have been treated with the UroLift
System in the U.S. 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 Prostatic Urethral Lift procedure 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 NeoTract | Teleflex Interventional Urology
A wholly owned subsidiary of Teleflex Incorporated, the 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 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®, UroLift® and Weck® – trusted brands united by a common sense of
purpose.
Mark Rochester is a paid consultant to NeoTract | Teleflex
Interventional Urology.
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Source: Teleflex Incorporated
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