Image courtesy Medtronic. Click to enlarge.

Medtronic (NYSE:MDT) said it won 510(k) clearance for a new, bone-growth-sparing system to treat life-threatening spinal deformities in young children called the Shilla growth guidance system.

The device is designed to replace "distraction-based" systems that must be adjusted every 6 to 9 months to accommodate growth in patients with early-onset conditions such as scoliosis, according to a press release. The 510(k) clearance is for skeletally immature pediatric patients less than 10 years old with severe, progressive, life-threatening, early-onset spinal deformities, Medtronic said.

"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," Shilla inventor Dr. Richard McCarthy of the University of Arkansas for Medical Sciences/Arkansas Children’s Hospital said in prepared remarks. "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 1st time we can offer effective management of the curvature of the spine while still harnessing the child’s natural growth."

The device works by using a non-locking set screw that allows the rod to slide as the child’s spine grows, according to the release.

"This clearance advances care for children with early-onset spinal deformities, and for their families and caregivers," spinal president Doug King said in prepared remarks. "We want to thank our surgeon partners and the FDA for helping us bring the SHILLA Growth Guidance System to an important patient population as we seek to address universal healthcare needs related to outcomes, costs and patient access."

Medtronic said the Shilla system won CE Mark approval in the European Union in 2012.