NICE has today (Wednesday 9 January), published new medical technology guidance supporting the use of a device to heal fractured bones.

TheNICE guidance advises that the EXOGEN ultrasound bone healing system benefits patients and the NHS when used for treating long bone fractures with non-union (bone fractures that have failed to heal after 9 months). However, the case for adopting EXOGEN routinely for long bone fractures with delayed healing, that is, fractures which do not show radiological evidence of healing after 3 months, wasn't supported because of uncertainties in the evidence.

EXOGEN delivers low-intensity pulsed ultrasound waves that aim to promote bone healing through stimulating the production of growth factors and proteins which increase the removal of old bone, and increase the production of new bone. Long bone fractures are suitable for treatment if the fracture is stable and well-aligned. 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.

Treating non-union fractures using EXOGEN shows high rates of fracture healing, with an estimated cost saving of £1164 per patient compared with current management. The saving is achieved through avoidance of surgical treatment. For delayed healing fractures, there is some radiological evidence of improved healing but there is too much uncertainty about the rate at which healing progresses between 3 and 9 months after fracture and about whether or not surgery would otherwise be necessary. These uncertainties make modelling the cost consequences of using EXOGEN in this scenario complex.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "We are pleased to publish final medical technology guidance which supports the use of EXOGEN for treating long bone fractures which have not healed after 9 months. NICE's independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to show that using the device in this situation resulted in high rates offracture healing. Using EXOGEN for treating long bone fractures which have not healed after 9 months is estimated to potentially save the NHS £1164 per patient compared with standard management, as surgery would be avoided. The device is also more convenient for patients as it's intended to be used in the patient's home.

"Whilst there is some evidence that EXOGEN can improve healing in fractures which have not healed after 3 months, there are uncertainties about the rate at which this healing progresses and whether or not surgery would be required. Because of these uncertainties, the modelling of the cost consequences was complex, and the case for the NHS routinely adopting EXOGEN for fractures which had not healed after just three months could not be supported.

"We hope that this guidance will be useful for NHS staff providing treatment for people with long bone fractures that have failed to heal after 9 months."

The guidance for EXOGEN is available at mtg12 .

ENDS

Notes to Editors

About the guidance

1. The medical technologies guidance, EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing, is available at mtg12 from Weds 9 January. Please contact the NICE press office for an embargoed copy.

2. The EXOGEN ultrasound bone healing system is manufactured by Smith & Nephew.

3. The potential for cost savings for use in non-union fractures is estimated at £1164 per patient compared with current management.

There is an estimated increased cost for use in delayed healing fractures of £504 per patient compared with current management.

4. The costs of the two types of EXOGEN device stated in the sponsor's submission are: £2562.50 (excluding VAT) for the EXOGEN 4000+ (used for non-union fractures) and £999.38 (excluding VAT) for the EXOGEN Express device (used for delayed healing fractures).

About the Medical Technologies Evaluation Programme

5. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

Further information about medical technologies.

About NICE

6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

7. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

8. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
• Commissioning Outcomes Framework - NICE develops the potential indicators for the COF, the scheme starting in 2013, which will help measure the health outcomes and quality of care commissioned by Clinical Commissioning Groups.

9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.