Evidence-based recommendations on the MAGEC system for spinal lengthening in children with scoliosis.
July 2019: NuVasive issued a Voluntary Field Safety Notice for MAGEC system devices manufactured before 26 March 2015. It says: ‘Fracture of the locking pin may affect the ability of the device to lengthen and may be associated with titanium wear debris generation and localised tissue discoloration. Post-market surveillance data have not revealed clinical symptoms related to localised tissue discoloration or titanium wear debris. Post-market surveillance data indicate that MAGEC system devices manufactured on or after 26 March 2015, do not exhibit the same issue.’
NICE has developed tools, in association with relevant stakeholders, to help organisations put this guidance into practice.
Is this guidance up to date?
In December 2018, NICE started the review of this guidance. To register as a stakeholder, please contact us at firstname.lastname@example.org.
Guidance development process
NICE medical technologies guidance addresses specific technologies notified to NICE by sponsors. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
Coding relevant to this guidance
Insertion of spinal growing system:
V41.1 Posterior attachment of correctional instrumentation to spine
Y70.5 Temporary operations
Adjustment of spinal growing system:
V41.8 Instrumental correction of spinal deformity, other specified
Y03.6 Adjustment to prosthesis in organ NOC
SNOMED CT preferred term (concept ID)
963391000000105 | Implantation of externally adjustable spinal deformity correction system (procedure)
For the adjustment:
963401000000108 | External adjustment of externally adjustable spinal deformity correction system (procedure)
Device (in UK Drug Extension only):
12234401000001101 | Internal spinal bracing and distraction system (physical object)
12234501000001102 | Externally adjustable internal spinal bracing and distraction system (physical object)
12234601000001103 | MAGEC internal spinal bracing and distraction system (Ellipse Technologies Inc.) (physical object)
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.