ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis. A press release reports that ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure compared to spinal fusion.

The press release adds that patient recovery is relatively pain-free and is measured in days, not months. The MID-C system acts as an “internal brace” with a patented unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allowing additional post-operative correction over time.

Baron Lonner (Mount Sinai Hospital, New York City, USA) says: “This FDA approval will enable surgeons to offer the first posterior dynamic deformity correction technology for treating Lenke Type 1 and Type 5 curves in patients with progressive adolescent idiopathic scoliosis. MID-C is an alternative that fills the significant treatment gap for patients between non-operative therapies and irreversible spinal fusion.”

Paul Mraz, CEO for ApiFix, comments: “FDA approval of ApiFix’s MID-C system is a significant achievement for our company. 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.”