Data shows the UroLift System provided significant improvements in
BPH symptoms, quality of life, and sexual function for men with an
obstructive median lobe
WAYNE, Pa.--(BUSINESS WIRE)--Dec. 14, 2018--
NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX)
focused on addressing unmet needs in the field of urology, today
announced the publication of 12-month data from the multi-center
prospective MedLift™ Study of the UroLift® System treatment
for Benign Prostatic Hyperplasia (BPH) in patients with an obstructive
median lobe. Results were published in Prostate Cancer and Prostatic
Diseases, a Nature Publishing Group journal.
The MedLift Study provided clinical evidence to support the safety and
efficacy of the UroLift System treatment for BPH, or an enlarged
prostate, involving a median lobe obstruction. Median lobe obstructions
are present in a subset of men with BPH. Results from this study led to
the recent U.S. Food and Drug Administration (FDA) clearance of an
expanded indication for the UroLift System, making patients who have an
obstructive median lobe eligible to receive the UroLift System treatment
for BPH symptoms.
“New options are needed for men with an obstructive median lobe, as
treatment can be particularly challenging. This condition can cause a
higher risk of urinary retention and result in a high failure rate of
medical therapy for lower urinary tract symptoms due to BPH,” said Dr.
Gregg Eure from Urology of Virginia in Virginia Beach, Virginia, a lead
investigator and co-author of the MedLift Study paper. “The outcomes of
this study, which showed significant and rapid improvements in BPH
symptoms and quality of life measures, demonstrate the safety and
effectiveness of the UroLift System for these patients.”
Data published from the MedLift Study show that patients who were
treated for obstructive median lobe with the UroLift System experienced
significant improvements in IPSS (International Prostate Symptom Score),
Qmax (peak flow rate), and QoL (quality of life) scores:
-
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
percent, respectively at 3, 6, and 12 months, p<0.0001).
-
Mean Qmax improvement ranged from 90-129 percent (p<0.0001).
-
At 1 month, 80 percent of men (95% CI 66- 89 percent) reported being
‘much’ or ‘very much better;’ and 89 percent (95% CI 76-95 percent)
would recommend the procedure.
-
Bother due to ejaculatory function improved rapidly and remained
modestly improved at 1 year (p=0.001). No patient reported de novo
sustained ejaculatory or erectile dysfunction.
“The MedLift Study provides additional evidence of the UroLift System’s
utility for the treatment of a broad range of men with BPH, allowing
more patients to benefit from this minimally invasive technology,” said
Dave Amerson, president of the Teleflex Interventional Urology business
unit. “The data from this study, among the many supportive findings from
a number of clinical and real-world studies of the UroLift System, have
helped the UroLift System become a standard of care treatment for
patients with BPH. Treatment with the UroLift System remains the only
BPH procedure shown to alleviate BPH symptoms without causing new onset,
sustained erectile or ejaculatory dysfunction.”
The outcomes from this study were consistent with those found in the
five-year pivotal L.I.F.T study of the UroLift System for patients with
lateral lobe enlargement, demonstrating rapid, significant, and
sustained improvements in symptoms and quality of life for patients who
have an enlarged median lobe, while also preserving their sexual
function with no instances of new, sustained erectile or ejaculatory
function. No differences were observed in symptom relief based on the
size of median lobe protrusion, and the majority of patients required
only one additional UroLift permanent implant in the median lobe to
achieve lasting relief from BPH symptoms.
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. Over 80,000 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 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.
Gregg Eure is a paid consultant to NeoTract | Teleflex Interventional
Urology.
MAC00912-01 Rev B
View source version on businesswire.com: https://www.businesswire.com/news/home/20181214005038/en/
Source: Teleflex Incorporated
For Teleflex Incorporated:
Jake Elguicze, 610.948.2836
Treasurer
and Vice President, Investor Relations
Media:
Nicole Osmer, 650.454.0504
nicole@healthandcommerce.com