Ellipse Technologies has received FDA 510(k) clearance to market its external remote controller (ERC 2) for use with the MAGEC spinal bracing and distraction system. The company says that the ERC 2 provides improved ergonomic handling and greatly enhanced user interfaces over the first generation ERC.
The MAGEC system consists of magnetic spinal rods and the ERC 2. It is a non-invasive distraction technology available for the treatment of early onset scoliosis. The MAGEC system eliminates painful repeated surgeries for distractions, typically performed every six months, which are required by other early onset scoliosis treatment options.
Through remote control, the MAGEC device can be non-invasively distracted in seconds in a precise, controlled manner after the initial implantation. This system enables a superior surgical technique advancement that is being widely adopted by surgeons who treat children with early onset scoliosis.
The elimination of repeated surgical distractions drastically reduces hospitalisation, neuro-monitoring, anaesthesia exposure, and the incidence of infection, enabling better outcomes for these children and providing overall cost savings in their treatment.
The MAGEC system is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities associated with or at risk of thoracic insufficiency syndrome. To date, the MAGEC system has been used in approximately 300 procedures in the USA and 1,500 procedures worldwide.