The US Food and Drug Administration FDA has given clearance to Medtronic for its TSRH Spinal, a pedicle screw system used to treat adolescent idiopathic scoliosis. For the second time, Medtronic receives FDA clearance for this indication. The company has been previously cleared for its CD Horizon pedicle screws.
“This additional adolescent idiopathic scoliosis clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with adolescent idiopathic scoliosis,” said Doug King, vice-president and president of Medtronic Spinal. “This clearance also provides an opportunity to further research and study these patients allowing us to move forward with our commitment and investment in paediatric innovation.”
TSRH and CD Horizon pedicle screws are indicated for posterior use as an adjunt to fusion in the thoracolumbar spine when treating adolescent idiopathic scoliosis.
The use of pedicle screw fixation in the paediatric population presents risks, including pedicle screw malpositioning, neurological or vascular injury, reduced longitudinal spinal growth, or risk for rotational spinal deformitites due to continued differential growth of the anterior spine. The safety and effectiveness of the TSRH and CD Horizon spinal systems have not been established for use as part of a growing rod construct. They are only intended to be used when definitive fusion is being performed at all instrumental levels.