All two-year follow up data for Axiomed’s USA lumbar Investigative Device Exemption clinical study has been collected and analysed, according to a company release.
Results from the lumbar European post-market assessment study showing clinically significant improvements in pain and disability were published in the International Journal of Spine Surgery.
One of the key conclusions of the study was the restoration of a centre of rotation, which mimics a healthy human disc and correlates in a clinically significant improvement in patient disability.
The AxioMed viscoelastic lumbar disc received CE mark in 2009 and has been used to treat over 500 patients with follow-up exceeding seven years.
