NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine

Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF

Excerpt from the Press Release:

SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify^® Cervical Disc (Simplify Disc) two-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the Journal of Neurosurgery: Spine. The data were utilized in the device’s FDA pre-market application for two-level indication approval, which was approved in April 2021.

The peer-reviewed publication reiterates that the Simplify Disc has a significantly greater success rate at the 24-month follow up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR).¹ Findings from this study include:

• Overall composite success rate was statistically significantly greater in the cTDR group compared to the ACDF group at 24-month follow up;
• Mean Neck Disability Index (NDI), a patient-reported measure for disability related to cervical spinal disorders, scores improved significantly in both groups, with the cTDR group having lower scores at all follow-up points;
• Neck and arm pain scores improved significantly in both the cTDR and ACDF groups; and
• Rate of subsequent surgical intervention was lower in the cTDR group compared to the ACDF group.

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