Medtronic Gets FDA Approval for Pediatric Scoliosis Treatment

Medtronic Inc. has a new weapon to use in its fight against scoliosis.

The world’s largest medical technology firm has received approval from the U.S. Food and Drug Administration (FDA) to use its CD Horizon Legacy Spinal System for the treatment of adolescent idiopathic scoliosis (AIS), a condition that affects nearly 6 million people in the United States (1 million of those patients are children). Characterized by a side to side curvature of the spine, AIS usually develops in children older than 10; its cause currently is unknown.

Medtronic’s CD Horizon Spinal System consists of rods, hooks, and screws that are implanted in the spine to correct the curve. The system is available in multiple rod diameters and screw sizes so surgeons can choose the appropriate size based on a child’s condition, anatomy, and activity level (3.5 millimeter rods are most commonly used in pediatric cases), according to the company’s 510(k) application to the FDA.

Doctors have used the CD Horizon Legacy Spinal System since 2004 in more than 500,000 surgeries. Medtronic applied for the 510(k) clearance to allow surgeons to use “pedicle screw-based constructs” to treat pediatric cases of AIS, the firm’s application stated. Besides information about the system such as materials used and precise sizes of components, Medtronic provided the FDA with published clinical data of pediatric AIS patients treated with the CD Horizon pedicle screw instruments. The data included the results of more than 600 pediatric patients treated with pedicle screw constructs alone and more than 900 patients treated with a hybrid construct of both pedicle screws and hooks.

“This is a major milestone for surgeons and their pediatric patients,” said Doug King, general manager of Medtronic’s Memphis, Tenn.-based spine business. “With this clearance we will now be able to provide training and education to surgeons to treat children diagnosed with AIS.”

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. In addition to giving pediatric AIS patients an alternative treatment for their condition, King said the FDA clearance will enable Medtronic to develop other technologies to help children with spinal conditions.

“The opportunity to further research and study this patient population will allow us to move forward with our commitment and investment in pediatric innovation,” he noted in a prepared statement.

David L. Skaggs, M.D., professor and chief of orthopaedic surgery at the Children’s Hospital in Los Angeles, Calif., said pedicle screws can help children retain their active lifestyles and possibly reduce the need for future surgeries.

“Using pedicle screws in the treatment of adolescent idiopathic scoliosis gives my patients the best chance of correcting their spine and chest deformities, and preventing future surgeries,” Skaggs said.