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FDA approves ApiFix MID-C system for progressive AIS

DateDecember 1, 2019
CategoriesCohort News
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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.

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