Interventional procedure overview of minimally invasive fusionless posterior-approach surgery to correct idiopathic scoliosis in children and young people
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Related NICE guidance
Interventional procedures
NICE interventional procedures guidance 728 (2022) on vertebral body tethering for idiopathic scoliosis in children and young people.
Recommendation
1.1 Evidence on the safety of vertebral body tethering for idiopathic scoliosis in children and young people is limited but raises concerns of serious complications. Evidence on its efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research. Find out what only in research means on the NICE interventional procedures guidance page.
1.2 Further research should include randomised controlled trials or analysis of registry data.
1.3 This procedure should only be done in specialist centres by spinal surgeons with specific training in anterior spinal surgery.
Medical technologies
NICE's medical technologies guidance 18 NICE's medical technologies guidance 18 on The MAGEC system for spinal lengthening in children with scoliosis (2014, withdrawn 2020).
April 2020: This guidance has been withdrawn while the MHRA conducts an investigation into the MAGEC system. The MHRA issued a Medical Device Alert MDA/2020/011 for all MAGEC systems. This is in response to the manufacturer's latest Field Safety Notice and previous field safety notices for problems that may require early removal of devices and lead to inadequate treatment.
The MHRA is not recommending prophylactic removal of devices but the supply of all MAGEC systems is suspended in the UK while the MHRA investigation is ongoing. The MHRA has set out the following actions:
Do not implant MAGEC rods in the UK until further notice.
Identify all patients implanted with a MAGEC System and ensure systems are in place to follow up these patients.
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