OrthoPediatrics: A possible replacement for spinal fusion surgery in kids
(Image courtesy of OrthoPediatrics)
OrthoPediatrics was working with ApiFix when the latter gained a Humanitarian Device Exemption for its eponymous scoliosis treatment device in 2019. OrthoPediatrics acquired ApiFix in April 2020.
The metal implant is designed to straighten the spines of children and teenagers as a replacement for braces, which can be hot and uncomfortable, and a possible replacement for spinal fusion surgery, which reduces spinal flexibility.
“For a long time, the Holy Grail in pediatric spine surgery is to figure out ways you can potentially do the same thing without actually having to fuse that child’s spine,” OrthoPediatrics president David Bailey told Medical Design & Outsourcing in an interview.
The ApiFix device, which is anchored by pedicle screws at the top and bottom of the spinal curve, has a one-way ratcheting mechanism that expands as the child grows. Pediatric orthopedic surgeons implant it during posterior surgery that takes about 90 minutes, according to Bailey.
The company is working with several major U.S. children’s hospitals and has reached 45 of the 200 implantations required by the FDA as part of its HDE.
“There is not extremely long-term data on how this is going to go,” Bailey said. “One thing we do know is that we certainly are giving these children or young adults a chance to drastically delay a life-changing fusion procedure or hopefully avoid altogether a fusion procedure.”
