Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its CD Horizon system to treat adolescent idiopathic scoliosis (AIS) for pediatric AIS patients treated with posterior pedicle screw instrumentation.
The CD Horizon Spinal system uses several screws, implants and other instruments to provide spinal stabilization and the correction of spinal deformities.
Medtronic said that the pedicle screws are designed specifically for use in the thoracolumbar spine and are frequently used in instrumentation procedures to affix rods to the spine to correct deformities.
Medtronic Spine business general manager Doug King said that this is a major milestone for surgeons and their pediatric patients and also added that with the clearance they will be able to provide training and education to surgeons to treat children diagnosed with AIS.
"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.
"Unlike adults, adolescent spines are still in a period of growth. Medtronic is committed to collaborating with the some of the world’s best surgeons to develop and advance technologies to address the unique needs of children."