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.
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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.
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By GlobalDataThe 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.
