The UroLift® System for the treatment of Benign Prostatic
Hyperplasia (BPH) was the subject of three presentations at the
Glasgow, Scotland-held urology event: a study of men with acute
urinary retention; 4D surgical techniques for insertion of UroLift
System implants and a single-centre study showing significant cost
savings with the use of the UroLift System treatment compared with
traditional surgery.
Teleflex Incorporated (NYSE:TFX) today thanked its United
Kingdom-based Physician Advocates for their Poster Presentations
highlighting the UroLift® System, as well as real world proof of
its cost effectiveness, at this year’s BAUS meeting which finished
on June 26th.
The first Presentation, by Dr. Mark Rochester*, Consultant
Urologist from Norfolk and Norwich University Hospital, shared
promising, early results of the UroLift System treatment of BPH
patients with acute urinary retention. Patients enrolled as part of
this four-centre U.K. study are some of the first of such patients
to have been treated with the UroLift System. Dr. Rochester said:
“Patients with acute urinary retention are faced with extremely
limited treatment options and have been previously excluded from
sponsored Prostatic Urethral Lift [PUL/UroLift System] studies,”
said Dr. Rochester. “These results demonstrate that the UroLift
System treatment can quickly and safely restore urinary flow in the
majority of patients with acute urinary retention, providing this
challenging patient population with a safe and effective
alternative to long-term catheter management and invasive BPH
treatment options.”
A second U.K. single-centre study showcased at BAUS examined
results from 50 patients all treated by Consultant Urologist Dr.
Neil Barber* of NHS Frimley Health Foundation Trust. The patients
who received UroLift System implants had an obstructive median lobe
or were treated using the 4D, or “stacking technique”. Results of
the study show statistically significant improvement in BPH
symptoms, quality of life and preservation of sexual function for
patients treated with the UroLift System, and were similar to the
results reported in the pivotal L.I.F.T. and BPH6 studies. Dr.
Barber said: “I used this new technique because, as in this
reported initial experience, it can be used in men with all shapes
of prostates including those men who would previously have been
deemed unsuitable candidates for the UroLift System treatment such
as those with obstructing median lobes.”
Results of a six-month retrospective study, presented by
Consultant Urologist Dr. Hemant Nemade of Northampton General
Hospital NHS Trust, showed that the UroLift System treatment was
more efficient than the current standard of care, Transurethral
Resection of the Prostate (TURP). Dr. Nemade said: “We have shown
that TURP is a costly and resource intensive procedure. In
comparison, the UroLift System procedure reduces costs and
increases efficiency, is easy to implement, and requiries a shorter
training time. Minimal infrastructure changes are needed in order
to fully adopt it as a preferred option for most men with BPH”.
The UroLift System will now benefit from support from the
Government’s Accelerated Access Collaborative (AAC) scheme to more
rapidly increase its uptake in the NHS. The AAC scheme enables
transformative products to reach patients as quickly as possible
through streamlined regulatory and market access decisions.
EMEA General Manager, Interventional Urology, Mr. Matt Wiggins,
said:
“Last September [2018], the UroLift System became one of the
seven products across all specialisms that Accelerated Access
Collaborative chose to support, enabling rapid increase in their
uptake.
“This is in addition to the national and regional support
funding mechanism that the UroLift System receives through the
ongoing inclusion in the Innovation and Technology Tariff, a
national scheme that NHS England created in order to help
innovative treatments reach patients more quickly. The UroLift
System will continue to benefit from the support of the Academic
Health Science Networks who have direct responsibility for
accelerating uptake locally.
“The big picture is that these Government support programmes for
the UroLift System are now in their third year and are enabling
urologists to offer this minimally invasive alternative to
traditional surgery to more BPH patients in NHS hospitals than ever
before.”
Mr Wiggins added: “For patients, the UroLift System can be life
changing. For clinicians, it is an enabling technology, allowing
them to deliver benefits for NHS urology departments in terms of
reducing overall costs and complications. It can save substantial
numbers of bed days and hours of operating theatre time. The
UroLift System potentially frees capacity for urologists to focus
on critical cancer targets and waiting times, reducing delays in
urgent and planned surgery.”
The UroLift System is the only BPH treatment option shown to not
cause new onset, sustained erectile or ejaculatory dysfunction.*1-5
It is a minimally invasive, true day case procedure which can be
performed under local anaesthesia. It offers a rapid improvement in
symptoms and a return to normal activity within days. Following
treatment, patients can usually go home without the inconvenience
and discomfort of a catheter.”1,6
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.*1,5 Patients
also experienced a significant improvement in quality of life. 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. 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 North America, Europe, Asia, Australia and New Zealand
and in Mexico and Puerto Rico. Learn more at www.UroLift.com.
About Teleflex Interventional Urology
The 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. *1,5 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® System and Weck® – trusted brands united
by a common sense of purpose.
*Dr. Neil Barber and Dr. Mark Rochester are paid consultants of
Teleflex Incorporated.
References:
*No instances of new, sustained erectile or ejaculatory
dysfunction
1. L.I.F.T. IDE Study. Roehrborn. J Urology 2013
2. AUA BPH Guidelines 2003, 2010, 2018
3. Naspro, Eur Urol 2009
4. Montorsi, J Urol 2008
5. McVary, J Sex Med 2016
6. Shore, Can J Urol 2014
MAC01108-01 Rev A.
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For Teleflex Incorporated: Jake Elguicze, 001 610.948.2836
Treasurer and Vice President, Investor Relations
Media: Amanda Hayhurst, Gloucester Road Communications 0044 772
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