Sam Brusco, Associate Editor04.25.22
NuVasive released results published in the Journal of Neurosurgery: Spine about its Simplify cervical disc two-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study. The data was used in the Simplify Disc’s FDA approval application for a two-level indication, which was approved in April 2021.
The publication reiterated that the Simplify Disc has a “significantly greater” success rate at 24 months of follow-up compared to anterior cervical discectomy and fusion (ACDF) when used in cervical total disc replacement (cTDR).
Overall composite success rate was statistically “significantly greater” for Simplify Disc users. Scores improved significantly for the mean Neck Disability Index (NDI), and neck and arm pain scores improved. Rate of subsequent intervention was also lower in the cTDR group.
"This peer-reviewed publication adds to the growing body of clinical evidence in support of the Simplify Disc," Kyle Malone, VP of Scientific Affairs at NuVasive told the press. "The Simplify Disc continues to demonstrate superiority in comparison to alternative techniques. As the most effective technology in the cTDR procedure segment, we are excited for the differentiated technology to help more patients around the globe."
The publication reiterated that the Simplify Disc has a “significantly greater” success rate at 24 months of follow-up compared to anterior cervical discectomy and fusion (ACDF) when used in cervical total disc replacement (cTDR).
Overall composite success rate was statistically “significantly greater” for Simplify Disc users. Scores improved significantly for the mean Neck Disability Index (NDI), and neck and arm pain scores improved. Rate of subsequent intervention was also lower in the cTDR group.
"This peer-reviewed publication adds to the growing body of clinical evidence in support of the Simplify Disc," Kyle Malone, VP of Scientific Affairs at NuVasive told the press. "The Simplify Disc continues to demonstrate superiority in comparison to alternative techniques. As the most effective technology in the cTDR procedure segment, we are excited for the differentiated technology to help more patients around the globe."