NuVasive scored FDA clearance for its spinal implant system for the treatment of early-onset scoliosis.
Picked up in Nuvasive’s $380 million acquisition of Ellipse Technologies, the MAGnetic External Control (MAGEC) Spinal Bracing and Distraction System is FDA-cleared for early-onset and idiopathic scoliosis. The new clearance is for the redesigned MAGEC system with the RELINE Small Stature system.
MAGEC uses magnetic technology with adjustable growing rods to treat scoliosis in a less invasive manner. Follow-up surgeries to change the rods’ length are not required—instead, an external remote controller is used to adjust the rods. The RELINE system is a comprehensive pediatric deformity fixation platform.
The new design includes components that make the system easier for a surgeon to use, and to make surgical outcomes more reproducible, the company said in a statement. The company is also introducing a new 5-millimeter rod. The RELINE system is the only small-stature system compatible with this rod size.
"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, in the statement. "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."
In March, the FDA cleared Nuvasive’s CoRoent Small Interbody System for the fusion of vertebral bodies—the main portion of each vertebra—for multiple levels in the cervical spine. It is used for the treatment of cervical disc degeneration, and is the first cervical cage system to be approved for the treatment of up to four adjacent levels of the spine.