NuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s Magec system to be surgically implanted using its Reline posterior fixation system for treating patients with severe spinal deformity conditions.
According to a company release, the Magec system is the only magnetically controlled growing-rod system cleared by the FDA for paediatric spinal deformity. Magec is designed to help surgeons reduce the number of planned surgeries required to effectively treat patients with early onset scoliosis.
Magec is comprised of a single-use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet controlled by an external remote controller. Periodic lengthening of the rod is performed in an office setting where the surgeon controls the implant externally, eliminating the need for a series of distraction surgeries used in the traditional surgical treatment for young patients.
The Reline portfolio is integrated with the company’s iGA platform to treat patients through traditional open or minimally-invasive procedures. Whether preserving or restoring spinal alignment, Reline’s single system is designed to address the spectrum of spinal pathologies from adult degenerative and deformity to specialised paediatric deformity.