NuVasive Receives FDA 510(k) Clearance Reinforcing Comprehensive Portfolio Supporting Pediatric, Adolescent and Adult Spinal Deformity Patients

SAN DIEGO, CA--(Marketwired - September 19, 2016) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it has received FDA 510(k) clearance for the Company's market-leading MAGEC® system to be surgically implanted using its Reline® posterior fixation system for treating patients with severe spinal deformity conditions.

The Company's MAGEC system is the only magnetically controlled growing-rod system cleared by the FDA for pediatric 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.

"The FDA 510(k) clearance is a key milestone for NuVasive as we continue to deliver new innovation to the spine market, and now more specifically, the pediatric deformity market. More importantly, it reflects an increased ability to better treat children with EOS. Combining the game-changing innovation of MAGEC and the versatility of Reline, we help transform the experience for these young patients. NuVasive is committed to partnering with surgeons to revolutionize deformity surgery for patients in need around the globe," said Jason Hannon, NuVasive's president and chief operating officer.

Sonia Garcia, a six-year-old patient suffering from EOS and severe kyphosis, was identified by Shriners International to need urgent spinal deformity correction surgery. Dr. Robert H. Cho, chief of staff and a leading pediatric orthopedic 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 innovative MAGEC rod, we have significantly impacted Sonia's life and minimized the number of surgeries she will require in the future. Immediately following her surgery, Sonia's lung capacity increased by more than 30 percent, 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 Dr. Cho.