Medtronic has received the US Food and Drug Administration (FDA) approval for its Texas Scottish Rite Hospital (TSRH) Spinal System Pedicle Screw to treat adolescent idiopathic scoliosis (AIS).
The TSRH Spinal System and CD Horizon pedicle screws are indicated for posterior use as an adjunct to fusion in the thoracolumbar spine when treating AIS.
Pedicle screws, in conjunction with autograft and/or allograft, are used in surgical procedures to affix rods to the spine to correct deformities.
Medtronic Spinal vice-president and president Doug King said this additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS.
"This clearance also provides an opportunity to further research and study these patients allowing us to move forward with our commitment and investment in pediatric innovation," King said.