Simplified Scoliosis Treatment Awarded CE Mark

In what may prove to be good news for victims of adolescent idiopathic scoliosis (AIA) ApiFix Ltd, of Misgav, Israel, has received the CE Mark for its own minimally invasive treatment system. Noting that today’s gold standard for correction of AIS involves the permanent spinal fusion of an average of 10 motion levels, the use of a large number of screws in a surgical procedure that lasts around six hours and costs upward of $100, 000.

ApiFix officials say that its ApiFix AIS correction system minimizes risk, pain and scarring for the patient; and speeds recovery time. They say that the shorter, simpler procedure costs less, as well.

In the ApiFix system, as the company’s release explains it, a doctor attaches a small implant to the center of the main spinal curvature using only two screws. This results in a 10 cm scar, compared to an over 40 cm scar in the standard procedure. After recovering from surgery, which takes about an hour, the patient undergoes physical therapy treatments, during which the implant is gradually “educating” the spine into a correct position and “remembers” and reinforces each correction made.

ApiFix recently 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, ” said Uri Arnin, ApiFix CEO. “Within about three months, we achieved an impressive result, while maintaining spinal flexibility.” With CE mark approval the company plans to begin marketing its device throughout Europe.