Ellipse Technologies received FDA 510(k) clearance to market its next generation external remote controller for use with the MAGnetic Expansion Control Spinal Bracing and Distraction System, or MAGEC system.
Here are five things to know:
1. The MAGEC system is intended for pediatric patients, younger than 10 years old,with severe progressive spinal deformities that are associated with or at risk of thoracic insufficiency syndrome.
2. The MAGEC system consists of magnetic spinal rods and the external remote controller. It is a non-invasive distraction technology.
3. The next generation external remote controller provides improved ergonomic handling and enhanced user interfaces over the first generation external remote controller.
4. The MAGEC system aims to eliminate the need for repeated surgical distractions.
5. The system has been used in approximately 300 procedures in the United States and 1,500 procedures worldwide thus far.