AxioMed has moved closer towards achieving US Food and Drug Administration (FDA) approval of its lumbar viscoelastic total disc replacement after submitting PMA Module II to the regulatory body.
According to AxioMed, the clinical data supporting the device is strong with range of motion identical to the range of the normal lumbar disc, with no reported device-related failures or revisions and rare cases of heterotopic bone formation.
Kingsley Chin, orthopaedic spine surgeon and chief technology officer at AxioMed, said: “The demand for disc replacement has been compounding over years in the USA, Europe and Australia and will J curve with the FDA approval of the superior AxioMed lumbar viscoelastic disc at the same time that we see more insurance coverage of disc replacement and patient awareness of the pitfalls of spinal fusions versus greater benefits of total disc replacements.”
Erik Spayde, orthopaedic spine surgeon at St Charles Spine Institute (Thousand Oaks, USA), commented: “With FDA approval of the AxioMed anterior lumbar disc, and to follow next with a lateral lumbar disc would allow me to perform my own access above L5-S1, so my fusion cases for degenerated intervertebral disc disease would soon be replaced by the AxioMed disc.”
The viscoelastic properties of the device allow for a single-piece design with four to 12 degrees of lordosis and which acts identical to the normal human disc to restore disc height and provide for shock absorption, the company states in a press release.
Vito Lore, vice president of Innovation for AxioMed’s parent company, the KICVentures Group, said: “We are grateful for the consistency demonstrated by our team to execute on the completion of each module to meet our targeted FDA submission dates.”
John Sullivan, vice president of Global Quality Affairs and Regulatory Compliance for the KICVentures Group, added: “We are already working on the third and final module to submit by April to complete the full FDA submission.”