Smith & Nephew has announced that the UK’s National Institute for Health and Clinical Excellence (NICE) has issued draft guidance supporting the case for utilising the Exogen Ultrasound Bone Healing System.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 is encouraging public comments on the use the technology 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 nine months after the fracture occurred.1
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.
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). In its press release Smith & Nephew says Exogen has been shown to heal 86 per cent of non-union fractures2 and accelerate the healing of fresh fractures up to 38 per cent faster than normal.3,4
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.
Smith & Nephew says 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.
“The publication of draft guidance on the use of Exogen in the routine treatment of long bone fractures with impaired healing is an important step in a process which has seen close collaboration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 strong evidence that Exogen has the potential to prevent significant numbers of patients with non-unions from requiring further complex surgery and consequently liberate valuable NHS resources. Additionally, there are known patient groups, such as those with diabetes and the elderly, who are at risk of not healing as might be expected due to their pre-existing conditions. The public consultation will allow patients, patient support groups and healthcare professionals to help define the appropriate use of Exogen so that these patients can get the best treatment while significant savings are made for the NHS.”
Source: Smith & Nephew PLC.