Smith & Nephew, the global medical technology business, announced today that the National Institute for Health and Clinical Excellence (NICE) has issued draft guidance supporting the case for utilising the EXOGEN®
Ultrasound Bone Healing System. NICE has opened a consultation period
regarding its draft findings and encourages public comments on the use of EXOGEN to treat long bone fractures that have either shown a delay in healing or have been clinically assessed as a non-union, meaning the bone has not healed 9 months after the fracture occurred.27
EXOGEN’s technology previously received positive NICE guidance in December 2010 when the organisation advised healthcare professionals that the use of low-intensity pulsed ultrasound represents a safe and effective treatment option to reduce the healing time in patients with fractures. The new guidance builds upon these results by looking at the health economics of EXOGEN to determine potential benefits to patients and cost savings to the NHS compared with surgical intervention
“The publication of draft guidance on the use of EXOGEN in the routine treatment of long bone fractures with impaired healing is an important step in a process which has seen close collaboration between Smith & Nephew and NICE,” said John Everett, Smith & Nephew’s VP of Commercial Operations for the Biologics business. “There is clearly evidence that EXOGEN has the potential to prevent significant numbers of patients from requiring further complex surgery and consequently liberate valuable NHS resources. There is a clear sub-set of patients who are at risk of not healing as might be expected and the public consultation will allow patients, patient support groups and healthcare professionals to define the appropriate use of EXOGEN so that patients can get the best treatment while significant savings are made.”
Manufactured by Bioventus LLC and distributed outside the United States by Smith & Nephew, EXOGEN is indicated in Europe to accelerate the healing of recent fractures and to heal bones that have either delayed healing or that simply have failed to heal (non-unions). EXOGEN has been shown to heal 86 percent of non-union fractures3
and accelerate the healing of fresh fractures up to 38 percent faster than normal.2, 7
EXOGEN is a portable, lightweight device that delivers the prescribed treatment in a convenient 20-minute daily regimen, self-administered at home by the patient. A digital display guides patients step-by-step through proper operation and the main unit monitors treatment – providing the clinician with an accurate record for reference.
EXOGEN is globally recognised as a safe treatment with no contra-indications or known side effects and is supported by robust and significant clinical data.
Michael Vinegrad, Smith & Nephew (01904 824135) email@example.comAbout Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
EXOGEN is a registered trademark of Bioventus LLC.Indications
In the EU the EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including: Treatment of delayed union and non-unions, 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 and treatment of joint fusion.
There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found at www.healmybone.com
or by calling 0845 272 5957.
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