Nice Supports the use of Low-Intensity Pulsed Ultrasound to Accelerate Bone Fracture Healing

By Smith Nephew, PRNE
Wednesday, December 15, 2010

Smith & Nephew's EXOGEN(TM) Ultrasound Bone Healing System Acknowledged as Efficacious and Safe Route to Rapid Recovery From Fractures

YORK, England, December 16, 2010 - The National Institute for Health and Clinical Excellence
(NICE) has advised healthcare professionals in the UK that the use of low
intensity pulsed ultrasound (LIPUS) technology represents a safe and
effective treatment option to reduce the healing time in patients with bone

NICE concluded that LIPUS technology provides clear clinical
benefit, particularly in patients experiencing delayed healing and non-union
fractures. The recommendation was made following analysis of clinical data
from over 1900 patients via a meta-analysis of 13 individual randomised
controlled trials (RCTs), information from additional RCTs and registry data,
plus specialist guidance from the British Orthopaedic Association (BOA) and
British Limb Reconstruction Society (BLRS).

Smith & Nephew's EXOGEN is indicated in Europe to accelerate
the healing of fractures and to heal bones that have either delayed healing
or stopped healing completely (non-unions).[i] EXOGEN has shown to heal 86
per cent of non-union fractures(2) and accelerate the healing of fresh
fractures up to 38 per cent faster than normal(3,4). Since the technology was
launched in 1997, it has been used successfully to heal fractures in hundreds
of thousands of patients worldwide.

"Today's guidance from NICE shows that low intensity pulsed
ultrasound is safe and has clear clinical benefits for patients with
fractured bones, especially those with or at risk of complications. I would
encourage healthcare professionals to utilise this important technology to
promote faster and more reliable healing of their injuries," said Mr Angus
, Consultant Orthopaedic Surgeon at Glasgow Royal Infirmary, Scotland.

"Doctors aim to return patients to normal function as soon as
possible following injury. EXOGEN is a treatment which is scientifically
proven to contribute to achieving this aim and can reduce the need for
painful surgery required as a result of poor or slow fracture healing, which
I encounter every day.

"By preventing complications before they occur and by
accelerating healing there is significant potential for this technology to
actually save money for the NHS and the public purse by reducing the need for
surgery and returning patients to work more quickly than before(5). Cost and
clinical effectiveness make a potential 'win-win' situation for the NHS and
the patient. I am convinced that today's announcement represents a
significant advance in patient care," added Mr MacLean.

Non-union fractures are defined as the point when bone healing
has stopped and will not proceed without some type of intervention. Three
studies conducted on non-union fractures demonstrated that use of EXOGEN for
20 minutes per day, with no other change in treatment, was highly successful
for a wide range of bones (with the exception of skull and vertebrae and
different types of fracture irrespective of the type of orthopaedic fracture

"Naturally, we are delighted at this positive guidance," said
John Everett, Vice President Commercial Operations, Smith & Nephew. "The
ultrasound technology utilised by EXOGEN can help the healing of fractures,
but most importantly it is the patient that really stands to benefit by
potentially avoiding further intervention and reducing their time to heal."

Notes to Editors:


EXOGEN(TM) utilizes low-intensity ultrasound to accelerate the
healing of fresh fractures up to 38 per cent faster than normal healing. This
treatment is often used for returning professional athletes to fitness as
quickly as possible. There are economic benefits generally for individuals
and organisations with people returning to work after injury more quickly.
Faster recovery is recognised to be in the interests of all patients,
clinicians and health care providers.

EXOGEN is also highly effective for use on non-healing fractures. These
fractures are a significant problem and a major cost to healthcare systems
globally. Patients who suffer fractures which will not heal are known to
suffer great frustration and anxiety. EXOGEN provides an improved chance to
recover, invaluable for patients who may have previously been largely
confined to hospital or their homes.

The EXOGEN device is a portable, lightweight unit that delivers the
prescribed treatment in a convenient 20 minute daily regimen,
self-administered in the home by the patient. The unit's digital display
guides patients step-by-step through proper operation and the main unit
monitors treatment - providing the clinician with an accurate record for

EXOGEN is globally recognised as a safe treatment with no
contra-indications, supported by robust and significant clinical data.

About Smith & Nephew

Smith & Nephew is a global medical technology business with
global leadership positions in Orthopaedics; including Reconstruction, Trauma
and Clinical Therapies; Endoscopy, including Sports Medicine; and Advanced
Wound Management.

Smith & Nephew is dedicated to helping improve people's lives.
The Company prides itself on the strength of its relationships with its
surgeons and professional healthcare customers, with whom its name is
synonymous with high standards of performance, innovation and trust. The
Company has distribution channels, purchasing agents and buying entities in
over 90 countries worldwide. Annual sales in 2009 were nearly $3.8 billion.


    1. NICE Interventional Procedures Guidance 374 on "Low-intensity pulsed
       ultrasound to promote fracture healing:
    2. Nolte et al (2001) Low Intensity Pulsed Ultrasound in the Treatment of
       Nonunions, J. Trauma 51 (4) 693-703
    3. Kristiansen et al (1997) J. Bone Joint Surg. 79A 961-973 Accelerated
       Healing of Distal Radial Fractures with the Use of Specific, Low-
       Intensity UltrasoundA Multicenter, Prospective, Randomized, Double-
       Blind, Placebo-Controlled Study
    4. Heckman JD, Ryaby JP, McCabe J et al. (1994) Acceleration of tibial
       fracture-healing by non-invasive, low-intensity pulsed ultrasound.
       Journal of Bone & Joint Surgery - American Volume 76:26-34.
    5. Taylor M, Posnett J,Trueman P. (2009) Evaluation of treatment options
       for fractured tibia; British Journal of Healthcare Management,15:9

    [i] Summary of indications

    Indications for Use

    The EXOGEN 4000+, or any other EXOGEN Ultrasound Bone Healing
    System is indicated for the non-invasive treatment of osseous defects
    (excluding vertebra and skull) that includes:

    - Treatment of delayed union and nonunions
    - Accelerating the time to heal of fresh fractures
    - Treatment of stress fractures
    - Accelerating repair following osteotomy
    - Accelerating repair in bone transport procedures
    - Accelerating repair in distraction osteogenesis procedures
    - Treatment of joint fusion

    Con Franklin/Sarah Swift, Red Door Communications
    Tel: +44(0)208-392-8040 /

Inquiries: Con Franklin/Sarah Swift, Red Door Communications, Tel: +44(0)208-392-8040, CFranklin at / SSwift at

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