NuVasive’s Simplify Disc Gains FDA Approval for Two-Level Cervical Total Disc Replacement

By Julie A. Vetalice

NuVasive’s Simplify Disc Gains FDA Approval for Two-Level Cervical Total Disc Replacement

The NuVasive Simplify® Cervical Artificial Disc was granted FDA approval for two-level cervical total disc replacement (cTDR).

It is one of three devices approved for use in two-level cTDR, including Medtronic's Prestige LP and the Mobi-C from Zimmer Biomet.

Simplify demonstrated clinical superiority at 24 months vs. anterior cervical discectomy and fusion (ACDF) in a two-level FDA Investigational Device Exemption study. In this study, the device proved an overall success rate that was nearly 10% higher when compared to ACDF.

Overall, the disc demonstrates clinical superiority to ACDF and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.

Simplify Disc was approved for one-level cervical procedures in 2020. The manufacturer, Simplify Medical, was acquired by NuVasive earlier this year.

Simplify is part of the NuVasive C360™ portfolio, which offers procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion and cTDR.

"This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio," said Massimo Calafiore, Executive Vice President, Global Business Units at NuVasive. "There is immense surgeon excitement for this latest edition to our cervical offering, and the expanded two-level indication provides greater opportunities to bring the most clinically effective technology in the cTDR market to more patients."

Product Labels: Cervical Spine, Spine Artificial Disc

Tags: Premarket Approval, Regulatory