Ellipse Technologies has announced the first implantation of the MAGEC (MAGnetic Expansion Control) spinal bracing and distraction system in the US since obtaining the US Food and Drug Administration’s (FDA) 510(k) approval in February 2014.
The MAGEC system was implanted in a progressive spinal deformity patient at Shriners Hospitals for Children – Philadelphia, the US.
The FDA has approved the MAGEC spinal bracing and distraction system for use in skeletally immature patients less than ten years of age with severe spinal deformities associated with, or at risk of, thoracic insufficiency syndrome.
In May 2013, first two cases in the US prior to the FDA clearance were performed under the administration’s compassionate use provision.
Ellipse Technologies has developed the MAGEC system as an alternative to traditional growing rods that require repeated lengthening surgeries throughout the child’s growing years.
The non-invasive procedure eliminates the need for repeated lengthening surgeries, resulting in significant health, psychological and socioeconomic benefits for the patients and their families.
Until now, the MAGEC system was used by more than 150 surgeons in 24 countries in the surgical treatment of more than 750 children.