The UK Medicines and Healthcare products Regulatory Agency (MHRA) has reinstated the use of the modified MAGnetic Expansion Control (MAGEC) X system for early onset scoliosis treatment, effective 23 February 2024.
Following an assessment by the MHRA, the UK lifted the suspension of the system, an orthopaedic spinal rod which can be used in skeletally immature patients.
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The MHRA extensively assessed the device’s safety measures implemented by its manufacturer NuVasive Specialized Orthopedics.
The modified MAGEC X system can now be used in surgeries for the treatment of early-onset scoliosis while complying with the manufacturer’s guidelines.
However, previous MAGEC system generations remain suspended in the UK.
Designed for children aged below ten years, the MAGEC X system is used to correct spinal deformities, reducing the need for repeated surgeries.
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By GlobalDataThe MHRA’s investigation into the device’s long-term safety prompted a voluntary suspension by the manufacturer in March 2020.
The agency investigated emerging data about ongoing technical failures with the device and evidence that it failed to endure the implantation time of six years under normal use conditions.
It identified safety concerns, leading to the suspension of the device’s CE certificate in March 2021.
Following the reinstatement of the certificate in November 2021, the MHRA set conditions for lifting the suspension, with advice from the Spinal Expert Advisory Group.
NuVasive has committed to post-market studies and clear usage instructions to ensure the MAGEC rods’ safety and performance.
The modified MAGEC X system includes design updates to address previous technical issues.
A press statement from the UK government reads: “Healthcare professionals, carers, and patients are asked to follow the guidance provided in the MHRA’s Devices Safety Information. Healthcare professionals should strictly follow the actions outlined in the manufacturer’s field safety notice.”
