ApiFix has secured FDA approval for its self-adjusting pediatric device designed to benefit young scoliosis patients with a less invasive surgical treatment
ApiFix, a medical devices manufacturer based in Misgav, Israel and Boston, Massachusetts, US, has received approval from the US Food and Drug Administration (FDA) to market its minimally invasive deformity correction (MID-C) system for the treatment of progressive adolescent idiopathic scoliosis (AIS).
AIS, the most common type of scoliosis, has no identifiable cause and affects around 3% of children between ages 10 and 21.
AIS curves progress during the rapid growth period of an adolescent. Most AIS curves slow their progression at the time of skeletal maturity. However, some deformities particularly curves greater than 50⁰, continue to progress during adulthood.
The MID-C technology from ApiFix is a posterior dynamic deformity correction (PDDC) system that allows surgeons to perform a treatment providing permanent curve correction while retaining spine flexibility.
ApiFix said that the procedures are less invasive compared to spinal fusion
The procedures are carried out through a less invasive surgical procedure compared to spinal fusion. The company claims that patient recovery is pain-free and is measured in days.
ApiFix CEO Paul Mraz 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.”
The MID-C system, which acts as an internal brace with a unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allows additional post-operative correction 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.”
ApiFix co-founder and chief technology officer Uri Arnin said: “We are grateful to FDA for this approval and we are excited to be in a position to offer a game-changing alternative to young patients in the United States.”