The ApiFix® system for correction of Adolescent Idiopathic Scoliosis has been used in 100 patients, to date, at 12 sites in nine countries.
The device is implanted in a minimally invasive procedure, does not require fusion and is designed to retain spinal flexibility. The earliest patients are now at four years post-op. At 1- to 3-year follow-up in 50 adolescent scoliosis patients reported in mid-2015, the ApiFix system revealed substantial curve correction and no implant failure.
ApiFix expects to double the number of cases by the end of 2017.
The device received approval under the CE Mark in 1Q13, and ApiFix is preparing a submission to FDA for a Humanitarian Device Exemption.
Sources: ApiFix Ltd.; ORTHOWORLD Inc.