OrthoPediatrics has announced the initial launch of the ApiFix minimally invasive deformity correction system in the USA.
Additionally, the company anticipates approximately 20 clinical centres in the country to enter data related to the use of the ApiFix system into a post-approval study registry hosted by the Pediatric Spine Study Group in order to continue monitoring the safety and probable benefit of the device for the treatment of progressive adolescent idiopathic scoliosis.
The ApiFix technology is a posterior dynamic deformity correction system approved for use in adolescent idiopathic scoliosis patients with Lenke type 1 and Lenke type 5 curves of 40 to 60 degrees and acts as an internal brace implanted unilaterally on the concave aspect of the curvature. It enables surgeons to perform a unique treatment and provide permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure compared to spinal fusion. Patient recovery is relatively pain-free and is measured in days, not months, the company says. The ApiFix system offers a patented unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allowing additional post-operative correction over time.
Paul Mraz, senior vice president of OrthoPediatrics and former president and CEO of ApiFix, commented: “ApiFix’s novel approach to correcting spinal deformity is a welcome medical advancement that has the ability to disrupt the continuum of care for scoliosis treatment in certain pediatric patients. Its elegant design and biomechanical considerations combined with the simplistic posterior approach is unmatched and provides a superior technology for treating adolescent idiopathic scoliosis. Now that the pause of elective surgeries due to COVID-19 is lifting, we look forward to initiating the commercial availability of the procedure in the USA and anticipate the first procedures to be performed in the coming weeks.”
Jeff Smithey, vice president of spine at OrthoPediatrics, added: “We are excited to begin providing access for this game-changing technology to children in the USA who are dealing with progressive scoliosis. The ApiFix system fills a major treatment gap after failed bracing and offers a viable treatment alternative potentially allowing patients to avoid fusion surgery with what we believe to be the least invasive surgical procedure for correcting scoliosis available in the world.”
ApiFix was acquired by OrthoPediatrics in April 2020 and operates as a wholly-owned subsidiary based in Israel.