Medtronic (NYSE: MDT) announced today it received clearance to treat adolescent idiopathic scoliosis (AIS). This marks the first such clearance by the FDA under the Agency’s newly established category for pediatric AIS patients treated with posterior pedicle screw instrumentation.
AIS is the most common type of scoliosis seen in children and affects nearly one million children in the U.S. alone. Scoliosis is a side to side curvature of the spine. AIS is defined as scoliosis whose onset occurs after 10 years of age and whose cause is essentially unknown.
“This is a major milestone for surgeons and their pediatric patients,” said Doug King, general manager of Medtronic’s 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. They are frequently used in instrumentation procedures to affix rods to the spine to correct deformities.
“The opportunity to further research and study this patient population will allow us to move forward with our commitment and investment in pediatric innovation,” said King. “Unlike adults, adolescent spines are still in a period of growth. Medtronic is committed to collaborating with the some of the world’s best surgeons to develop and advance technologies to address the unique needs of children.”
David L. Skaggs, MD, Professor and Chief of Orthopaedic Surgery at the Children’s Hospital in Los Angeles says getting children back to their active lives and potentially reducing the need for additional surgeries are two key advantages of using pedicle screws.
“Using pedicle screws in the treatment of Adolescent Idiopathic Scoliosis gives my patients the best chance of correcting their spine and chest deformity, and preventing future surgeries,” said Dr. Skaggs.
Source: Medtronic’s Spine Business
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