NICE is consulting on the potential impact of a new device that aims to straighten and lengthen the spine of children with scoliosis.
Draft guidance from the National Institute for Health and Care Excellence supports the case for using Ellipse’s MAGEC system in children aged 2-11 years who have scoliosis, a curvature of the spine, but for whom standard methods to straighten the spine, such as wearing a back brace, have not worked.
Scoliosis is a condition where the spine curves abnormally to one side. In around 90% of cases, no treatment is needed because the spine corrects itself as the child grows. If treatment is needed, a back brace can stop the spine from curving further. This brace is worn until the child stops growing. Other standard options include using an external plaster cast or growth rods that are surgically inserted around part of the spine. These standard rods are then extended twice a year via small incisions in the back; a procedure performed under general anaesthetic and which may require an overnight stay in hospital. As the child grows, they will gain more height from having a straighter spine than from one that is curved. Fusing the spine is the final option, but this limits spinal growth so is normally avoided.
The MAGEC system includes one or two extendable titanium rods which are surgically inserted and attached to the spine or ribs above and below the curved section of spine. This procedure to implant the rods is similar to that used for conventional rods. However, the main difference is that the MAGEC system does not need periodic surgical incisions in the back in order to lengthen the rods. Instead, using a magnet and screw system that sits within the rod, the length of the MAGEC system rod can be increased using a remote control device. This can be done in an outpatient clinic, and does not need a general anaesthetic.
By avoiding the need for the repeated surgical procedures, the committee accepted claims that the device can reduce the incidence of surgical complications and infections, cause less pain and distress and less time away from school
The device manufacturer claims that benefits of the MAGEC system include avoiding repeated surgical procedures, leading to a reduced incidence of surgical complications, including anaesthetic risk and delayed recovery; a reduction in psychological trauma to the child and family; and improved quality of life due to less time needed away from school. Based on modelling, the savings from using the MAGEC system is estimated at around £12,000 per patient after six years compared with standard growth rods.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “For children who need treatment for scoliosis, and for whom standard treatment such as a back brace hasn’t worked, surgery to implant conventional growth rods is an option. But the repeated surgical procedures that are needed to extend the rods can be difficult for the child and their family or carers, and can cause distress.
“In this draft guidance, the independent Medical Technologies Advisory Committee (MTAC) considered there was evidence to support the use of the MAGEC system to help straighten and lengthen the spine in children aged between two and 11 years.
“By avoiding the need for the repeated surgical procedures, the committee accepted claims that the device can reduce the incidence of surgical complications and infections, cause less pain and distress and less time away from school. The use of MAGEC was estimated to potentially save the NHS around £12,000 per patient after six years compared with using conventional growth rods. We welcome comments on the draft guidance during this consultation.”
The consultation closes on 25 February.
Click here for details.
