Evidence Summary
The ApiFix procedure is backed by more than nine years of clinical experience. The ApiFix system is FDA approved as a humanitarian use device for use in the treatment of adolescent idiopathic scoliosis (AIS).
Review Indications for Use, Contraindications, Warnings, and Precautions
The first ApiFix procedure was performed in April 2012. Since then, more than 900 AIS patients have been treated with the ApiFix procedure. During this time, the implant system, surgical technique, and patient indications have evolved.
The current system, which includes three pedicle screws with an extension rod proximally, and current indications, that now include lateral side-bending ≤ 30 degrees, were introduced in 2017.
ApiFix has also initiated a Post-approval Registry to further study and evaluate the continued safety and probable benefit of the ApiFix procedure for 5 years post-implantation in AIS patients.
Two recent publications reported on patients with minimum 2-year follow-up treated with earlier versions of the ApiFix system:
Floman et al., Vertebral growth modulation by posterior dynamic deformity correction device in skeletally immature patients with moderate adolescent idiopathic scoliosis.3
Retrospective study to determine if ApiFix modulated growth in skeletally immature AIS patients. Outcomes include:
Floman et al., Surgical management of moderate adolescent idiopathic scoliosis with a fusionless posterior dynamic deformity correction device: interim results with bridging 5–6 disc levels at 2 or more years of follow-up.4
Retrospective review of ApiFix patient outcomes, which include:
A number of preclinical tests were undertaken to assess durability, wear resistance, and range of motion of the ApiFix system. Findings of these tests include:
1Success rate is defined as primary Cobb angle less than or equal to 35 degrees and no curve progression at follow-up intervals compared to baseline following treatment with the ApiFix System. Target Population with Extender Consistent with Surgical Technique Guide; 6 month follow-up (N=20); 12-month follow-up (N=8).
2Target Population with Extender Consistent with Surgical Technique Guide; N=47
3Floman Y, El-Hawary R, Lonner BS, Betz RR, Arnin U: Vertebral growth modulation by posterior dynamic deformity correction device in skeletally immature patients with moderate adolescent idiopathic scoliosis. Spine Deformity: Published online August 21, 2020; DOI: https://link.springer.com/article/10.1007/s43390-020-00189-z
4Floman Y, El-Hawary R, Millgram MA, Lonner BS, Betz RR: Surgical management of moderate adolescent idiopathic scoliosis with a fusionless posterior dynamic deformity correction device: interim results with bridging 5–6 disc levels at 2 or more years of follow-up. Journal of Neurosurgery: Published online January 10, 2020; DOI: https://doi.org/10.3171/2019.11.SPINE19827
5Arnin U, El-Hawary R, Betz RR, Lonner BS, Floman Y: Preclinical Bench Testing on a Novel Posterior Dynamic Deformity Correction Device for Scoliosis. Spine Deformity: 7(2019)203-212. DOI: https://doi.org/10.1016/j.jspd.2018.08.010
6Holewijn RM, Kleuver MD, van der Veen AJ, et al: A Novel Spinal Implant for Fusionless Scoliosis Correction: A Biomechanical Analysis of the Motion Preserving Properties of a Posterior Periapical Concave Distraction Device. AO Spine: Published online April 7, 2017; DOI: https://journals.sagepub.com/doi/10.1177/2192568217699377
ApiFix Ltd.
1 Hacarmel Street
Kochav Yokneam Bldg.
Yokneam Illit 2069207
ISRAEL
OrthoPediatrics Corp.
2850 Frontier Drive
Warsaw, IN 46582
USA
T. 1-877-268-6339
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