The ApiFix system, which has now been used to correct scoliosis in 50 adolescents since the system was approved for marketing in Europe, has continued to demonstrate encouraging results at one-to-three years of follow-up with 25 of these patients.
“Scoliosis curve correction at one-to-three years follow-up is substantial for these adolescents. Equally important, patients are pain-free and happy with their new back shape. No implant failure has been observed,” said Yizhar Floman, principal investigator for the ApiFix clinical study.
ApiFix is a commercial-stage company that has developed the CE-marked ApiFix system—a non-fusion minimally invasive treatment alternative for adolescent idiopathic scoliosis (AIS). Scoliosis surgery is the most invasive procedure in spine, and the average procedure fuses 10 vertebrae together using 20 screws, resulting in significant and permanent loss of spine mobility.
“While the reduction in spine mobility is certainly a difficult consequence of long spinal fusions, which are the gold standard of treating scoliosis today, other critically important negative consequences include high chance for back pain and additional spine surgery during the first 20 years post-original surgery,” said Uri Arnin, chief executive officer.
A clinical study of the ApiFix system led by Yizhar Floman and published this year in the journal Scoliosis concluded that “there are many drawbacks to the current gold standard of AIS surgery, which are almost nonexistent with the use of ApiFix: considerable blood loss leading to blood transfusions, neurologic deficit including spinal cord lesions, late infections, pseudoarthrosis, limitation of spinal motion also affecting non-fused levels, back pain and disc degeneration in the non-fused spinal segments. Almost all of these complications can be avoided by the use of Apifix.”