NuVasive, a medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, has received FDA 510(k) clearance for the company’s MAGEC® system to be surgically implanted using its Reline® posterior fixation system for treating patients with severe spinal scoliosis.
The Company’s MAGEC system is the only magnetically controlled growing-rod system cleared by the FDA for paediatric spinal deformity. MAGEC helps surgeons reduce the number of planned surgeries required to effectively treat patients with Early Onset Scoliosis (EOS). Supported by the versatility of the Reline system, NuVasive now offers surgeons a comprehensive solution for treating the most difficult spinal deformities.
A case study by NuVasive looked at Sonia Garcia, a six-year-old patient suffering from EOS and severe kyphosis, who was identified to need urgent spinal deformity correction surgery. Robert Cho, chief of staff and a leading paediatric orthopaedic surgeon at Shriners Hospitals for Children Los Angeles, accepted the case.
“When I first met Sonia, she had a poor chance of surviving past her late teens. Because of her severe scoliosis, her quality of life was declining secondary to her lungs becoming collapsed and constricted by her progressive spinal curvature. Leveraging the versatility and reliability of Reline with the MAGEC rod, we have significantly impacted Sonia’s life and minimised the number of surgeries she will require in the future. Immediately following her surgery, Sonia’s lung capacity increased by more than 30 per cent, she reclaimed 10cm of height and her future is bright. This is why I do what I do, to help improve and change lives,” said Cho.