NICE Interventional Procedure Guidance recommends use of prostatic urethral lift
implants under "normal arrangements", the least restrictive classification
PLEASANTON, Calif.--(BUSINESS WIRE)-- NeoTract, Inc., today announced that the
UK's National Institute for Health and Clinical Excellence (NICE) has issued an
interventional Procedure Guidance (IPG) approving the UroLift(R) prostatic lift
system for use by UK doctors. The NICE guidance was made following consultations
with independent clinical experts and a literature review.
NICE says: "The specialist advisers listed key efficacy outcomes as symptom
improvement, improvement in quality of life, reducing or stopping medical
therapy [drug therapy], flow improvement, reduction in residual volume and
maintenance of sexual and ejaculatory function".
The NICE IPG means that UK urologists will be able to routinely offer the novel
UroLift system to their patients for the first time outside of a clinical trial.
The implants are used to treat BPH - a condition caused by an enlarged prostate
that begins to obstruct the urinary system. The condition is common, affecting
over 40% of men over 50 years of age. BPH symptoms can include urgency,
hesitation, straining, dribbling, incomplete emptying (the sensation that the
bladder is not empty after urinating), weak urine flow, increased frequency of
urination, nocturia, dysuria, and depression resulting in a decreased quality of
Patients receiving the UroLift implants report rapid symptomatic improvement,
increased urinary flow rates, and preserved sexual function. A significant
improvement in Quality of Life for patients was also observed.
Unlike all other permanent treatment options for enlarged prostates that require
administration of a spinal or a general anesthetic, the minimally invasive
procedure to insert the UroLift implants typically lasts less than an hour, can
be carried out under local anesthesia and the patient is able to go home shortly
afterwards; the procedure provides significant Improvements without significant
downsides and rapid symptom relief.
Mr Neil Barber, Consultant Urologist at Frimley Park Hospital in Surrey says:
"Up to now, men with BPH have had two pretty unattractive options - either
lifelong drug treatment which is less effective than surgery and has possible
side effects including sexual dysfunction, dizziness and headaches, or cutting
away parts of the prostate - known as TURP - that is really good at relieving
BPH symptoms but has a significant chance of causing permanent dry orgasms and
erection problems, and a small chance of developing urinary incontinence. That's
not much of a choice. Many men I see in clinic are, understandably, very nervous
of having TURP - they may be older but they are men - so whatever their age,
they don't want to have an operation which may make them feel less of a man.
[The] UroLift [implant] involves retracting and holding back the enlarged
prostate so it's gentler than TURP with minimal side effects and it's more
effective than drugs. I think it's a really exciting, game changing treatment
for men. UroLift [implants] add another option in the armamentarium for some men
and is particularly useful in those who want to quickly return to their normal
activities and preserve sexual function."
Urologist Professor Tom McNicholas, who works at the London Clinic and Spire
Hospital, Harpenden, as well as in the NHS, has been involved since the start of
the project. He says: "Several leading UK surgeons have been using UroLift
[implants] for a while now. But there are always difficulties in introducing a
new idea and it's reassuring and encouraging that NICE have rigorously assessed
[the] UroLift [system treatment] and regard it as both safe and effective. We
now hope to use UroLift more widely in the NHS and in the private sector now
that NICE has supported it. I have been involved in an NHS pilot research study
on the UroLift device because we saw that, aside from the clinical value of the
procedure, there were savings and efficiencies that could be achieved by reduced
bed stays for this day case procedure - compared to the other, more invasive
surgical procedures that are available. I am looking forward to offering it to
my NHS patients because UroLift [implants] improve symptoms whilst preserving
men's sexual function and these are worthwhile and important outcomes."
Mr Mark Speakman, Consultant Urologist at Taunton's Musgrove Park Hospital,
says: "The UroLift [prostatic implant] procedure is a middle ground option for
men sitting between drug treatment and surgical transurethral resection of the
prostate (TURP). The problem of drug treatment is compliance - men aren't good
at taking drugs - and the problem with TURP is the potential side effects,
including ejaculatory problems. UroLift [implantation] beats drugs on efficacy
and TURP on side effects. Many men have contacted us wanting UroLift, and the
announcement will make life easier for British surgeons who want to offer it."
"Receiving NICE interventional procedure guidance is another huge milestone for
UroLift(R) and NeoTract." commented Dave Amerson, president and CEO of NeoTract.
"We are extremely pleased to bring our innovative UroLift System to more
physicians and patients in the U.K. as we believe it will make a significant
difference in the lives of aging men."
About BPH and the UroLift System Treatment
BPH is a common condition afflicting more than 500 million ageing men worldwide.
Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss
of productivity and sleep, depression and decreased quality of life. Medication
is often the first line therapy but relief can be inadequate and temporary.
Side-effects 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 or heats prostate tissue to open the blocked
urethra. Although effective, patients have to 'earn' their symptom relief after
a difficult period of irritative voiding symptoms and catheterization. Even the
'gold standard' surgery, TURP (Transurethral Resection of the Prostate), can
leave patients with permanent side-effects such as urinary incontinence,
erectile dysfunction and retrograde ejaculation (dry orgasm).
The UroLift System is designed to open the urethra directly without applying
incisions, surgical resection or thermal injury to the prostate. Obstructive
prostate lobes are transurethrally pushed aside and small permanent UroLift
implants hold the lobes in the retracted position, thus opening the urethra
while leaving the prostate intact. Learn more at www.UroLift.co.uk.
The UroLift System is currently available for patients in Europe, Australia and
Canada and was FDA approved in 2013.
NeoTract, Inc. 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 device designed to
treat lower urinary tract symptoms (LUTS).
Gloucester Road Communications
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Source: NeoTract, Inc.