Teleflex Incorporated (NYSE: TFX) today announced the results of
four studies that were accepted at the ICS 2020 Annual Meeting –
Online reinforcing the safety and efficacy of the UroLift® System
for the treatment of benign prostatic hyperplasia (BPH).
“BPH commonly causes bothersome urinary symptoms that can affect
quality of life. With over 40% of men over the age 50 living with
BPH,1 the robust data presented at ICS highlight the advantages of
the UroLift System as a preferred treatment option for many men
suffering needlessly from BPH symptoms,” said Dave Amerson,
president of the Teleflex Interventional Urology business unit.
“Prostatic Urethral Lift, or PUL, using the UroLift System is an
effective and durable treatment for BPH, and a frequent
recommendation to my patients who experience difficulties voiding
as a direct symptom of BPH,” said Thomas Mueller+, M.D., New Jersey
Urology. “The enlarged prostate presses on and can block the
urethra, causing bothersome urinary symptoms. The results of PUL
studies presented at ICS indicate that it is a safe and effective
option for men with BPH.”
Dr. Mueller’s oral presentation, Results from the Large
Real-World Study of the Prostatic Urethral Lift (PUL) Demonstrate
Consistent Safety and Effectiveness for BPH Patients, was a
recipient of the Best In Category Prize for Male Lower Urinary
Tract Symptoms (LUTS). The clinical research was designed to expand
upon the growing body of evidence of the effectiveness, safety and
symptomatic relief of PUL for BPH in a real-world retrospective
study. This was the largest real-world investigation of PUL, with
male participants averaging 70 years old. Results confirmed that
PUL can be offered to a wide patient population in a real-world
setting while maintaining the symptomatic improvement and safety
profile observed in the pivotal LIFT trial.
UroLift System treatment efficacy was further confirmed in the
real-world setting with Parallel Outcomes of the Prostatic Urethral
Lift from Two Distinct Multicenter Real-World Studies, presented by
Karl-Dietrich Sievert+, M.D., Klinikum Lippe, Detmold Germany. Two
published real-world studies, the German Multicenter Retrospective
Study and the Large Real-World Retrospective Study, of PUL were
compared to assess UroLift System performance. In non-retention
subjects, symptom response, quality of life (QoL), and Qmax
outcomes were largely consistent between the two real-world
studies. Catheter-independence rates of retention subjects were
also equivalent, with 86% independence in the German Multicenter
Retrospective Study and 87% independence in the Real-World
Retrospective Study.
Prostatic Urethral Lift (PUL) Can Reduce Voiding Bladder
Pressure Demonstrated by Penile Cuff Test was presented by Brian
Mazzarella+, M.D., of Midtown Urology. This was the first study to
evaluate real-world penile cuff testing (PCT) outcomes in men with
BPH before and after PUL. Outcomes in International Prostate
Symptom Score (IPSS) (p=0.03), QoL (p=0.2) and flow improvement
(p=0.1) improved significantly at three months. Using PCT,
researchers demonstrated that penile cuff pressure measurements
improved by 16% three months after PUL (p=0.07), and 44% of
subjects moved out of the obstructed flow category.
The Mechanism of Action of the Uniquely Designed Prostatic
Urethral Lift Implant was authored by Daniel Rukstalis+, M.D.,
Prisma USC Division of Urology. This study evaluated the short-term
and long-term mechanisms of action of PUL using the UroLift System
implant. Twenty-four canines who underwent PUL were evaluated for
histopathology. Resected prostate tissue from human subjects was
also analyzed to provide further insight into the previously seen
symptomatic improvements in humans treated with PUL. The results of
the study show that the UroLift System immediately causes localized
compression, and sustained pressure by implants results in
subsequent tissue remodeling and scarring which contributes to
durability of symptom relief.
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 (*50 years outside US). 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. 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. Thomas Mueller, Dr. Karl-Dietrich Sievert, Dr. Brian
Mazzarella and Dr. Daniel Rukstalis are paid consultants of
NeoTract | Teleflex Interventional Urology
____________________
1. Berry, S.J., et al., The Development of Human Benign
Prostatic Hyperplasia with Age, J Urology 1984; 132: 474-4792.
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
*No instances of new, sustained erectile or ejaculatory
dysfunction in the L.I.F.T. pivotal study† Management estimate
based on product sales and average units per procedure
Contacts:For Teleflex Incorporated:Jake
Elguicze, 610.948.2836Treasurer and Vice President, Investor
Relations
Media:Nicole Osmer,
650.454.0504nicole@healthandcommerce.com
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