NeoTract’s Minimally Invasive UroLift® System for Enlarged Prostate Now Shown to be Durable Through Five Years: Results from Pivotal L.I.F.T. Randomized Study Presented
Long-Term Findings Show Sustained Symptom Relief and Improved Quality
of Life For First-Line Treatment
PLEASANTON, Calif. & LONDON–(BUSINESS WIRE)–NeoTract, Inc., a medical device company focused on addressing unmet
needs in the field of urology, today announced five-year follow-up data
from the pivotal, randomized L.I.F.T. IDE study, which evaluated the
safety and effectiveness of the company’s novel UroLift®
System in patients with symptomatic benign prostatic hyperplasia (BPH).
Claus Roehrborn, M.D., professor and chair of the Department of Urology
UT Southwestern Medical Center in Dallas and co-principal investigator
for the L.I.F.T. clinical program, presented the results at the 18th
annual European Urological Association meeting in London.
“The UroLift System is truly a new standard for the treatment of BPH.
This conclusion of the landmark L.I.F.T. randomized clinical trial
offers high quality clinical data that demonstrate the durable benefits
this unique treatment option can offer,” said Dr. Roehrborn. “The
UroLift System treatment delivers a truly minimally invasive patient
experience: it can be performed efficiently and effectively under local
anesthesia, typically without the need for a postoperative urinary
catheter. Symptom relief is achieved rapidly, within two weeks, and at
one month is very similar to what can be expected at five years. Serious
side effects of traditional surgery are avoided, and the UroLift System
treatment is the only procedure shown to not cause sustained sexual
issues.”
“I believe that the UroLift System should be considered an early
treatment option for men with BPH, given the safety and benefits of the
procedure and the large number of patients for whom pharmaceutical
therapy is either insufficient or intolerable due to side effects, cost
or inconvenience.”
Results of the five-year L.I.F.T. study demonstrate that UroLift System
treatment provides:
- A highly tolerable, minimally invasive procedural experience;
-
Rapid reduction of symptoms after the procedure while preserving
sexual function; -
Sustained effect, with IPSS (International Prostate Symptom Score) and
Qmax (peak urinary flow rate) remaining 36% and 44% improved from
baseline, respectively; - Quality of life (QoL) score improvement of 50% over five years;
- A durable treatment with a low retreatment rate of 2-3% per year.
“This excellent long-term data reinforces our enthusiasm about the
UroLift System treatment becoming the standard of care first-line
treatment for men unhappy with BPH medications,” said Dave Amerson,
president and CEO, NeoTract, Inc. “Adoption of the UroLift System
continues to grow rapidly. We are excited to partner with urologists to
help men return to normal urinary function and preserve sexual vitality
with this safe and effective treatment option – the only BPH procedure
that does not require cutting, heating or removal of the prostate
tissue.”
Additional data from the L.I.F.T. clinical trial will be presented at
the 2017 American Urological Association (AUA) conference taking place
May 12-16 in Boston.
More than 37 million men in the United States are affected by BPH, which
occurs with advancing age when the prostate gland that surrounds the
male urethra becomes enlarged and begins to obstruct the urinary
system. Symptoms of BPH often include sleepless nights and urinary
problems, and can cause loss of productivity, depression and decreased
quality of life.
Medication is often the first-line therapy for enlarged prostate, but
relief can be inadequate and temporary. Side effects of medication
treatment can include sexual dysfunction, dizziness and headaches,
prompting many patients to quit using the drugs. For these patients, the
classic alternative is surgery that cuts, heats or removes prostate
tissue to open the blocked urethra.
About the UroLift System
The FDA-cleared UroLift System is a novel, 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.
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 is available in the U.S.,
Europe, Australia and Canada. Learn more at www.UroLift.com.
About NeoTract
NeoTract, Inc. is dedicated to developing innovative, minimally invasive
and clinically effective devices that address unmet needs in the field
of urology. The company’s 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.
Contacts
for NeoTract, Inc.
In the United States:
Nicole Osmer,
650-454-0505
nicole@healthandcommerce.com
or
for
NeoTract, Inc.
In Europe:
Amanda Hayhurst, 44-772-0205581
Amanda@amandahayhurst.com
