Medtronic Obtains Second Clearance for AIS Treatment System

Medtronic Inc. has received a second clearance from the U.S. Food and Drug Administration for its TSRH (Texas Scottish Rite Hospital) Spinal System, which is designed to treat adolescent idiopathic scoliosis (AIS) with pedicle screws.

“This additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS,” 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 pediatric innovation.”

The use of pedicle screw fixation in the pediatric population presents several risks, including pedicle screw malpositioning, neurological or vascular injury, reduced longitudinal spinal growth, or risk for rotational spinal deformities (the “crankshaft phenomenon”) due to the continued differential growth of the anterior spine. The TSRH Spinal System is designed to be used only when definitive fusion is being performed at all instrumented levels.

Medtronic is headquartered in Minneapolis, Minn; its spine business is based in Memphis, Tenn. The TSRH system was created in collaboration with the Texas Scottish Rite Hospital in Dallas, Texas.