Teleflex Interventional Urology Expands Portfolio with Introduction of the UroLift® Advanced Tissue Control (ATC)™ System
October 28 2020 - 6:30AM
Teleflex Incorporated (NYSE: TFX) today announced the expansion of
its UroLift® System portfolio with the introduction of the UroLift®
Advanced Tissue Control (ATC)™ System. The new system, which builds
on the highly successful UroLift System, features a number of
enhancements to enable urologists to more easily treat benign
prostatic hyperplasia (BPH) patients with challenging anatomies,
including an obstructive median lobe and large lateral lobes. The
UroLift ATC System will be launched on a limited basis while the
business unit expands its capacity to meet demand.
The UroLift ATC System was cleared by the U.S. Food and Drug
Administration (FDA) in June 2020 to treat BPH, including lateral
and median lobe hyperplasia, in prostates up to 100cc in men 45
years of age or older. The standard UroLift System was previously
cleared by the FDA in late 2017 for median lobes. Although only a
small percentage of patients have an obstructive median lobe, the
UroLift ATC System further enhances the ability to treat these
anatomies.
The new UroLift ATC System delivers the same proven UroLift
implant through an enhanced delivery device tip. It features tissue
control wings that hold tissue during manipulation, enabling the
urologist to mobilize obstructive tissue and pin it to the side to
enhance visualization and open up the blockage caused by the
enlarged prostate. The tissue control wings are strategically
shaped to optimize the view of obstructing tissue. The UroLift ATC
System also includes a needle location marker with laser-etched
markings that can aid with targeting accuracy for predictable
implant placement.
“We are encouraged by early positive responses from urologists
to the UroLift ATC System. Urologists are reporting high
satisfaction with its ease of use and indicating their willingness
to adopt the new device in their practices to treat patients with
challenging anatomies, including obstructive median lobe and large
lateral lobes,” said Dave Amerson, president of the Teleflex
Interventional Urology business unit.
“My experience with the UroLift ATC System has been
overwhelmingly positive,” said Steven Gange, M.D.+, Salt Lake City,
Utah. “The new design features of the UroLift ATC System make it
easier for me to treat patients with complex anatomies, and
especially increase my confidence in treating patients with an
obstructive median lobe.”
The UroLift System has consistently achieved statistically
significant results in patients with an obstructive median lobe;
the new UroLift ATC System will make it easier to handle the more
complex anatomy of these patients. Data published from the MedLift
Study showed that patients who were treated for obstructive median
lobe with the standard UroLift System experienced significant
improvements in IPSS (International Prostate Symptom Score), Qmax
(peak flow rate), and QoL (quality of life) scores:1
- Mean IPSS improved from baseline by at least 13.5 points
(p<0.0001).
- Quality of life and BPH Impact Index scores were improved
(>60% and >70%, respectively at 3, 6, and 12 months,
p<0.0001).
- Mean Qmax improvement ranged from 90-129% (p<0.0001). At one
month, 80% of men (95% CI 66- 89%) reported being ‘much’ or ‘very
much better,’ and 89% (95% CI 76-95%) would recommend the
procedure.
- Bother due to ejaculatory function improved rapidly and
remained modestly improved at one year (p=0.001). No patient
reported de novo sustained ejaculatory or erectile
dysfunction.
About the
UroLift® SystemThe UroLift System is
a minimally invasive treatment for lower urinary tract symptoms due
to benign prostatic hyperplasia (BPH). It is indicated for the
treatment of symptoms of an enlarged prostate up to 100cc in men 45
years or older. The UroLift permanent implants, delivered during an
outpatient procedure, relieve prostate obstruction without cutting,
heating, or removing prostate tissue. The UroLift System is the
only leading BPH procedure shown to not cause new onset, sustained
erectile or ejaculatory dysfunction in the L.I.F.T pivotal
study.2-5 Most common adverse events are temporary and can
include hematuria, dysuria, micturition urgency, pelvic pain, and
urge incontinence.2 Rare side effects, including bleeding and
infection, may lead to a serious outcome and may require
intervention. As with any medical procedure, individual results may
vary. Consult the Instructions for Use (IFU) for more information.
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. More than 200,000 men have been treated with the
UroLift System in select 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 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.**2,4,5 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. Steven Gange is a paid consultant of
NeoTract/Teleflex*Management estimate based on product sales and
average units per procedure**No instances of new, sustained
erectile or ejaculatory dysfunction in the L.I.F.T pivotal
study
Contacts:For Teleflex Incorporated:Jake
Elguicze, 610.948.2836Treasurer and Vice President, Investor
Relations
Media:Nicole Osmer, 650.454.0504nicole@healthandcommerce.com
1. Rukstalis et. al, Prostate Cancer and Prostatic Diseases 2018
MedLift Study2. Roehrborn, J Urology 2013 LIFT Study3. Roehrborn,
Can J Urol 2017 5 Year LIFT Study4. AUA BPH Guidelines 2003, 20205.
McVary, J Sex Med 2016
MAC01742-01 Rev A
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