ApiFix has received US Food and Drug Administration (FDA) approval through a Humanitarian Device Exemption (HDE) to commercialise its Minimally Invasive Deformity Correction (MID-C) system to treat progressive adolescent idiopathic scoliosis (AIS).
AIS is a form of scoliosis that occurs in children of ages ten to 21. AIS curves generally progress during the adolescent period and slow by the time the patient reaches skeletal maturity.
In cases where curve progression is more than 50˚, scoliosis can advance even at adulthood.
ApiFix CEO Paul Mraz said: “FDA approval of ApiFix’s MID-C system is a significant achievement for our company. More importantly, it makes 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.”
The technology is a posterior dynamic deformity correction (PDDC) system that provides permanent curve correction and also retains the flexibility of the spine.
The MID-C is an internal brace equipped with a unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints that can allow additional corrections over time.
ApiFix co-founder and chief medical officer Yizhar Floman said: “The FDA rigorously evaluated data from patients treated with ApiFix’s MID-C system since 2012 to demonstrate the safety and probable clinical benefits of our less invasive, non-fusion deformity correction system.”
The MID-C system has secured FDA and CE Mark approvals and is currently available in the US, Canada, Europe, Israel and Singapore.