The system, which has CE Mark clearance for the European Union, has been used to treat over 50 patients since approval, according to the Israel-based company.
“Scoliosis surgery is the most invasive procedure in spine. Now, there is a minimally invasive alternative for many of these children and adolescents. 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,” Apifix clinical trial principal investigator Dr Yizhar Floman of the Israel Spine Center said in a press release.
While most treatments for scoliosis require spinal fusion, the ApiFix system does not use fusion, avoiding the potential for loss of spine mobility, according to Apifix.
The company said they are continuing to track 25 patients after positive 1 to 3 year follow ups.