(RTTNews) - NuVasive, Inc. (NUVA), Tuesday announced that the NuVasive Simplify Cervical Artificial Disc received approval from the U.S. Food and Drug Administration for two-level cervical total disc replacement.
"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."
The Simplify Disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion 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. Additionally, a greater percentage of patients achieved success in a 15-point Neck Disability Index (NDI) and had no neurological deterioration components in relation to fusion.
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