Medtronic Inc. has received a second clearance from the Food and Drug Administration for its TSRH Spinal System, which is designed to treat adolescent idiopathic scoliosis with pedicle screws.
AIS is the most common pediatric spine condition, and it causes patients to have rotated or curved spines. The cause is unknown, but if the condition isn’t treated, it could compress nerve roots and the spinal cord.
While the use of pedicle spine screws has some risks, the clearance allows Fridley-based Medtronic (NYSE: MDT) to continue to research the product and its uses. The surgery is used to halt spinal curves from worsening and reduce spinal deformity to restore spine stability and alignment.
“This additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS,” Doug King, vice‐president and president of Medtronic Spinal, said in a statement.
The TSRH system was developed by a collaboration between Medtronic and the Texas Scottish Rite Hospital in 1987. and was launched as a product in 2009.