ApiFix Gains FDA Approval for MID-C Scoliosis Treatment

By Julie A. Vetalice

ApiFix received FDA approval under a Humanitarian Device Exemption to market the MID-C Minimally Invasive Deformity Correction system to treat adolescent idiopathic scoliosis (AIS).

FDA claims this to be the first posterior non-fusion device to treat adolescents with idiopathic scoliosis.

MID-C was developed as a less invasive motion-preserving alternative to fusion to treat progressive scoliosis in a select group of AIS patients. The system provides permanent curve correction while retaining spine flexibility. 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.

Source: ApiFix Ltd.

Tags: Regulatory