FDA approves ApiFix MID-C system for progressive AIS
Israeli medical devices manufacturer ApiFix has bagged approval from the US Food and Drug Administration (FDA) for marketing its minimally invasive deformity correction system (MID-C system) or the treatment of progressive adolescent idiopathic scoliosis (AIS) through a humanitarian device exemption (HDE).
Considered to be the most common form of scoliosis, adolescent idiopathic scoliosis impacts 2-3% of children in the age group of 10 to 21 with no detectable cause. The disease progresses during the rapid growth period of an adolescent.
Adolescent idiopathic scoliosis curves slow their progression during the time of skeletal maturity by a significant extent. But, few deformities like curves more than 50⁰, continue to progress through adulthood.
Yizhar Floman – ApiFix co-founder and chief medical officer 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 technology of ApiFix is a posterior dynamic deformity correction (PDDC) system that helps surgeons to carry out a treatment that gives permanent curve correction while retaining spine flexibility.
Compared to spinal fusion, the procedures with the MID-C system are done through a less invasive surgical procedure. The company said that the patient will be recovered in days and recovery is comparatively pain-free.
Paul Mraz – AoiFix CEO said: “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.”
According to ApiFix, the MID-C system works as an internal brace with a unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints that enable additional post-operative correction over time.