Regulatory Focus™ > News Articles > Draft Recommendation by NICE Offers Split Decision on Bone Healing Device

Draft Recommendation by NICE Offers Split Decision on Bone Healing Device

Posted 15 August 2012 | By Louise Zornoza

The UK's National Institute for Health and Clinical Excellence (NICE) has opened a consultation on its draft medical technology guidance on the use of a device to heal fractured bones.

The draft guidance recommends use by the National Health System (NHS) of Smith & Nephew's EXOGEN ultrasound bone healing system in treating long bone fractures that have failed to heal after 9 months. Long bone fractures are suitable for treatment if the fracture is stable and well-aligned.

EXOGEN delivers low-intensity pulsed ultrasound waves that stimulate bone healing by promoting the production of growth factors and proteins which increase the removal of old bone, and increase the production of new bone. Ultrasound waves are delivered straight to the fracture site via a small transducer which is secured by a strap. For patients wearing a cast, a hole is cut to allow the transducer to make contact with the skin at the fracture site. The device is programmed to deliver ultrasound in 20-minute sessions which the patient administers themselves each day at home.

Cost Effective at 9 Months

According to Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, "The independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to support the use of EXOGEN for treating long bone fractures which have not healed after 9 months.

"In this situation, using the device resulted in high rates of fracture healing. This use was estimated to potentially save the NHS £1164 per patient compared to standard management as surgery would be avoided."

Longson noted the device also represented a more convenient form of treatment for patients, who would be able to use the device at home instead of going to a physician for the same.

A Split Decision

While the device is recommended for treatment of fractures not healed after 9 months, the same recommendation was not extended to fractures unhealed after three months. "There were uncertainties about the rate at which healing progresses and whether surgery would otherwise be needed," Longson explained. "The cost modeling was therefore complex, and the case for routine adoption in the NHS could not be convincingly made. We welcome comments on the draft guidance as part of the current consultation."


Read more:

NICE - EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing

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