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 Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).
The Simplify 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.1 In this study, the device proved an overall success rate that was nearly 10% higher when compared to ACDF.1 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.1 Overall, the Simplify Disc demonstrates clinical superiority to ACDF1 and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.2 It is one of three devices approved for use in two-level cTDR procedures.
https://finance.yahoo.com/news/nuvasives-simplify-disc-receives-fda-200300755.html
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