Teleflex Incorporated (NYSE: TFX) today announced the publication
of positive results from a multi-center study reaffirming the
safety and effectiveness of the minimally invasive
UroLift® System for the treatment of benign prostatic
hyperplasia (BPH) in real-world patient populations. This is the
largest, most comprehensive study to examine a minimally invasive
BPH procedure in a real-world setting. Results were published in
the Journal of Endourology.
The Real-World Retrospective study was designed to
evaluate the safety and effectiveness of the UroLift System in a
real-world setting and to determine whether clinical outcomes are
consistent with those found in controlled studies. The
multi-center, retrospective study examined the results of 1,413
consecutive patients who received the UroLift System treatment over
two years across 14 sites in North America and Australia.
“Not only are the real-world results from this
large, multi-center study consistent with the L.I.F.T study, this
study also provides data in populations of patients who were not
studied in the L.I.F.T study but are seen in a real-world clinic
setting,” said Gregg Eure, M.D., urologist at Urology of Virginia
in Virginia Beach, Virginia, a lead investigator and co-author of
the study. “These findings should give urologists and patients the
confidence to adopt the UroLift System within the broader BPH
population.”
The randomized L.I.F.T. clinical trial demonstrated
that treatment with the UroLift System provides patients rapid and
durable symptom relief.1,2 The minimally invasive procedure, which
works without cutting, heating, or removing prostate tissue,
demonstrates an excellent safety profile and preserves sexual
function.1,2,10 Unlike BPH thermal therapies such as the most
recent steam treatment, the real-world results for the UroLift
System treatment showed complication rates and a patient experience
that were consistent with controlled clinical trials.3-8
Data published from the study show that patients
from multiple subgroups treated with the UroLift System experienced
improvements in IPSS (International Prostate Symptom Score) and QoL
(Quality of Life) score:
- Consistent with the L.I.F.T. study, symptoms improved
significantly from baseline at all follow up time points through
two years, and most perioperative adverse events were mild to
moderate, resolving by four weeks
- In a cohort-matched comparison to L.I.F.T. study patients with
moderate-severe symptoms (IPSS ≥13), symptom improvement was
similar at all time points
- Of the 165 patients in retention at baseline, 83% became
catheter-free by one-month post-procedure and 87% were
catheter-free by the end of the study; IPSS scores were similar to
non-retention patients
- In the 73 patients with prior prostate cancer treatment, mean
IPSS improved at all time points with no significant difference in
adverse events of interest compared to other patients
- IPSS improvement was similar regardless of prostate volume
(< 30cc; 30cc to <80cc; ≥80cc)9
“With over 100,000 men treated worldwide, the
UroLift System has become an accepted standard of care treatment
for BPH that provides patients rapid symptom relief and recovery,”
said Dave Amerson, president of the Teleflex Interventional Urology
business unit. “We are pleased that these highly positive results
continue to demonstrate that outcomes found in a real-world setting
are consistent with those in the pivotal L.I.F.T study, and also
highlight the effectiveness and versatility of the UroLift System
treatment for BPH in diverse patient populations.”
Findings from this large, multi-center study
support the application of the UroLift System in the broader BPH
population, including challenging patients such as those in
retention and those who have been treated for prostate cancer.
Individuals with lower prostate volumes (<30cc) experienced
significant symptomatic relief with a favorable safety profile,
highlighting the unique benefits of the UroLift System for these
patients. Unlike some BPH thermal therapies, the indication for the
UroLift System has no lower limit on prostate volume.
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.1,10 Patients also experienced significant
improvement in quality of life.1 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.1 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.1,10 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. Gregg Eure is a paid consultant 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________________________________________1.
Roehrborn, et al., J Urol 2013; 190(6): 2161-72.
Roehrborn, et al., Can J Urol 2017; 24(3): 8802-88133.
Darson, et al., Res Rep Urol 2017; 9: 159-1684.
Mollengarden, et al., Prostate Cancer Prostatic Dis 2018;
21(3): 379-3855. Mooney, et al., J Urol 2019; 201(4S):
PD10-11 AUA abstract6. Yang, et al., 2018; WCE 2018
Poster 2018, UP3-337. McVary et al., J Urol 2016;
195(5): 1529-15388. McVary, et al., J Sex Med 2016;
13(6): 924-339. UroLift System is contraindicated for
prostates >80cc in the US and >100cc outside the
US10. No instances of new, sustained erectile or ejaculatory
function
Teleflex (NYSE:TFX)
Historical Stock Chart
From Feb 2024 to Mar 2024
Teleflex (NYSE:TFX)
Historical Stock Chart
From Mar 2023 to Mar 2024