BOSTON–(BUSINESS WIRE)–ApiFix Ltd., a leading motion-preservation scoliosis correction company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) via a Humanitarian Device Exemption (HDE) to market the Minimally Invasive Deformity Correction (MID-C) system for the treatment of progressive adolescent idiopathic scoliosis (AIS).
AIS is the most common type of scoliosis with no identifiable cause and affects 2%-3% of children between ages 10 to 21. Generally, AIS curves progress during an adolescent’s rapid growth period and, while most curves slow their progression significantly at the time of skeletal maturity, some deformities, especially curves greater than 50°, continue to progress during adulthood.
“FDA approval of ApiFix’s MID-C system is a significant achievement for our company,” said Paul Mraz, CEO for ApiFix Ltd. “But more importantly, it makes a notable treatment advancement available for patients and their families who want FDA approved alternatives to permanent spinal fusion. Our MID-C System addresses a significant unmet clinical need for a motion-preserving alternative to spinal fusion and is a viable treatment option for progressive scoliosis in a select group of AIS patients.”