Regulatory Focus™ > News Articles > UK Clears New Bone Healing Device for NHS Use

UK Clears New Bone Healing Device for NHS Use

Posted 10 January 2013 | By Louise Zornoza

The UK cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has issued final guidance recommending the use of Bioventus' innovative new bone healing device EXOGEN to treat long bone fractures that have failed to heal after 9 months.

The device sends ultrasound waves to the fracture site and is intended for home use by the patient.  According to NICE's independent Medical Technologies Advisory Committee (MTAC), use of the device resulted in high rates of fracture healing without the need for surgery.

The EXOGEN device delivers low-intensity pulsed ultrasound waves with the aim of stimulating bone healing. It is thought that healing is promoted by stimulating the production of growth factors and proteins that increase the removal of old bone, increase the production of new bone and increase the rate at which fibrous matrix at a fracture site is converted to mineralized bone. Long bone fractures are suitable for treatment if the fracture is stable and well-aligned. EXOGEN is not indicated for use in fractures of the skull or vertebrae, or in children or adolescents because of their skeletal immaturity.

NICE's Medical Technologies Evaluation Program was established in 2009, with a focus on the evaluation of innovative medical technologies, including devices and diagnostics. The types of medical devices evaluated by the Program are those that are implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. 

Read more:

Read all Breaking News from RegLink


Regulatory Focus newsletters

All the biggest regulatory news and happenings.