NuVasive (Nasdaq:NUVA) today announced data from an FDA investigational device exemption study supporting its Simplify cervical disc.
San Diego-based NuVasive’s two-level FDA IDE study data was recently published in the Journal of Neurosurgery: Spine and utilized in the device’s FDA pre-market application for two-level indication approval, which NuVasive received in April 2021.
The peer-reviewed publication includes data demonstrating significantly greater success rate with the Simplify disc at the 24-month follow-up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR), according to a news release.
Overall composite success rate was statistically significantly greater in the cTDR group compared to the ACDF group at 24 months. Mean Neck Disability Index scores improved in both groups, with the cTDR actually scoring lower at follow-up points, while neck and arm pain scores improved significantly in both groups.
The rate of subsequent surgical intervention was lower in the cTDR group compared to the ACDF group, NuVasive said.
NuVasive’s Simplify cervical artificial disc, part of its NuVasive C360 portfolio, is comprised of PEEK on ceramic materials to allow for enhanced visualization through MRI postoperatively when compared to alternative devices.
“This peer-reviewed publication adds to the growing body of clinical evidence in support of the Simplify Disc,” NuVasive VP of Scientific Affairs Kyle Malone said in the release. “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.”