This is a simple concept, but probably the cleverest idea we’ve seen for a while. And now spinal device specialist, ApiFix Ltd., has received CE Mark for its minimally invasive treatment system for Adolescent Idiopathic Scoliosis (AIS). ApiFix also reports that it has successfully completed a pilot clinical trial with positive results.
Today’s gold standard for correction of AIS involves permanent spinal fusion of an average of 10 motion levels. The surgical procedure lasts around six hours and costs upward of $100,000. The AIS surgery market is currently estimated at approximately $700 million, with some 70,000 procedures annually.
Probably equally significant is the fact that this shorter, simpler procedure costs less. ApiFix says surgery takes only about an hour, after which the patient undergoes physical therapy treatments. The really clever bit is the combined effect of physio with an automatically adjusting implant. In effect, by advancing by a notch or two under physio, the correction becomes progressive. The implant gradually “educates” the spine into a correct position and “remembers” and reinforces each correction made. Mainly though, the system allows the soft tissues to adapt and accommodate to incremental corrections.
Recently, ApiFix successfully completed a pilot clinical trial in Europe, during which implants were executed in patients suffering from AIS.
“The results demonstrate the implant’s safety and success in correcting the curvature,” noted Uri Arnin, ApiFix CEO and an entrepreneur with vast experience in the spinal implants field. “Within about three months, we achieved an impressive result, while maintaining spinal flexibility.”
Source: ApiFix, PR Newswire