FDA Clears NuVasive’s Redesigned MAGEC System

NuVasive Inc., a medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the company’s redesigned MAGEC system with its RELINE Small Stature system. NuVasive will feature these new product offerings at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course held September 6-9, 2017 in Philadelphia.
 
The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.
 
RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5.0 millimeter MAGEC rod.
 
“As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod,” said Matt Link, executive vice president of strategy, technology, and corporate development at NuVasive. “The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market.”
 
NuVasive has reached meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years and is a leading sponsor of SRS. The company’s ‘Embracing the Journey Together’ initiative includes pediatric spinal deformity research, education and spinal deformity event support, assisting leading surgeons as they educate other surgeons around the world.