FDA clearance of Medtronic's scoliosis implant a much-needed victory for pediatric devices

Shilla Growth Guidance System--Courtesy of Medtronic

Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's ($MDT) Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.

Childrens' rapid growth make developing implants for early onset scoliosis challenging, explained the device's inventor, Dr. Richard McCarthy of Arkansas Children's Hospital. "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," he said in a statement. "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."

Medtronic says the device overcomes the growth issue thanks to nonlocking screws at both ends of the device that enable its rod to slide as the child grows. The device received a CE mark in 2012 and has been used to treat patients in 17 countries on three continent's, according to the release.

Others are working to develop devices for early onset scoliosis as well. Privately-held Spineform LLC last year received a $1.6 million grant from the FDA to fund the Phase II study of its device, known as the HemiBridge system.

The FDA also funds pediatric medical device consortia to encourage the development of child-specific or child-friendly devices. And in April a final rule requiring new device applications to list more information about a condition's pediatric subpopulation took effect.

• read the release