NuVasive (NSDQ:NUVA) announced today that it received FDA approval for its Simplify disc in two-level cervical total disc replacement (cTDR).
San Diego-based 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, according to a news release.
Simplify is anatomically designed and includes 4mm, 5mm and 6mm options, while the proprietary design allows for a variable center of rotation for each treated level to closely mimic the motion dynamics of a natural spine segment.
The disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA investigational device exemption (IDE) study. The device also delivered an overall success rate that was nearly 10% higher when compared to ACDF.
“This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio,” NuVasive EVP of global business units Massimo Calafiore said in the release. “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.”