ApiFix · raw details

ApiFix provides a minimally invasive scoliosis correction system for treating patients with adolescent idiopathic scoliosis whoare classified as Lenke type 1 or type 5 with a Cobb angle of 40 to 60 degrees. Unlike traditional scoliosis correction procedures,which tryto fix the deformity in one aggressive and complex operation, the ApiFix system is based on a minimal surgical intervention and a correction process that spans several months and incorporates the aid of physical therapy. The ApiFix Internal Brace System is attached to the spine viatwo pedicle screws that are inserted on both sides of the apex of the major curve. The incision is approximately 10 cm long, and the procedure takes about one hour. The expandable rod located between the two screws incorporates a miniature ratchet mechanism that captures incremental deformity corrections while the patient performs side-bending exercises to the corrective direction at home for six months after the operation. In August 2019, the company received approval from the US Food and Drug Administration via a humanitarian device exemption to market the minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis.