Medtronic Earns FDA Clearance for Shilla Growth Guidance System

Medtronic Inc.’s spine division, Medtronic Spine, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Shilla growth guidance system, and the Memphis, Tenn.-based division will be launching the system immediately in the United States. The system earned CE mark approval in 2012.

Shilla is designed to treat skeletally immature pediatric patients less than 10 years of age diagnosed with severe, progressive, life-threatening, early onset spinal deformities. According to Medtronic, it is a growth-sparing technology that allows correction of the deformity while maintaining the corrections over time, minimizing the need for periodic lengthening procedures. This is different than current operative treatments, which are distraction-based systems that require lengthening every six to nine months.

“Early onset scoliosis is extremely difficult to treat. The current gold standard technique to manage scoliosis long-term is to fuse the spine, but in children who are still growing this can have serious complications,” said Shilla inventor Richard McCarthy, M.D., an orthopedic surgeon and faculty member at the University of Arkansas for Medical Sciences/Arkansas Children’s Hospital. “Until now we were only able to offer operations which use implants to stabilize the curve in the spine, but these frequently mean twice-yearly surgeries as a child grows. The clearance of the Shilla growth guidance system marks the first time we can offer effective management of the curvature of the spine while still harnessing the child’s natural growth.”

The Shilla growth guidance system uses a non-locking set screw at the proximal and distal portions of the construct’s rods. This specific feature is designed to allow the rod to slide through the screw heads as the child’s spine grows, while still providing correction of the spinal deformity.

“This clearance advances care for children with early-onset spinal deformities, and for their families and caregivers,” said Doug King, senior vice-president and president of Medtronic Spinal.

The CE mark was Shilla’s first regulatory approval, and since 2012 has been used in 17 countries on three continents.