Medtronic Inc. (NYSE:MDT) received Food & Drug Administration 510(k) clearance for its CD Horizon vertebral bone screw system for treating scoliosis that develops during adolescence.
It’s the first clearance by the FDA under its new category for pediatric adolescent idiopathic scoliosis patients who are treated with posterior pedicle screw instruments, Medtronic said in a release.
The clearance also may help the Minnesota medical device giant revive its struggling Memphis, Tenn.-based spine business, which is near the end of a three-year overhaul just as insurers take a harder look at whether surgery is the most cost-effective way to treat back pain, according to a Reuters analysis.
"This is a major milestone for surgeons and their pediatric patients,” said Doug King, general manager of Medtronic’s Spine business, in prepared remarks.
“With this clearance, we will now be able to provide training and education to surgeons to treat children diagnosed with AIS.”
Adolescent idiopathic scoliosis is the most common type of abnormal spine curvature in children and affects nearly one million children in the United States alone, Medtronic said. AIS occurs between 10 years of age and adulthood.
Pedicle screws platforms like Medtronic’s new system are often are used to affix rods to the spine to correct deformities like scoliosis.
“Using pedicle screws in the treatment of adolescent idiopathic scoliosis gives my patients the best chance of correcting their spine and chest deformity, and preventing future surgeries,” said Dr. David L. Skaggs, professor and chief of Orthopedic Surgery at Children’s Hospital in Los Angeles, Caliornia, in the Medtronic statement.
Pedicle screws also can enable children to get back to their active lives and may reduce the need for additional surgeries and cost, Skaggs said.
“The opportunity to further research and study this patient population will allow us to move forward with our commitment and investment in pediatric innovation,” King said.