Two-level FDA Investigational Device Exemption study data reiterates that NuVasive’s Simplify Disc has a significantly greater success rate at 24-month follow-up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR).
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, 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
Rate of subsequent surgical intervention was lower in the cTDR group compared to the ACDF group
Simplify is part of the NuVasive C360™ portfolio which offers procedurally integrated solutions for the anterior and posterior cervical spine, including ACDF, cTDR and posterior cervical fusion (PCF) procedures. Overall, the Simplify Disc demonstrates clinical superiority to ACDF and has the highest overall clinical success rate compared to any other approved cervical disc for two-level use.
Two-level FDA Investigational Device Exemption study data reiterates that NuVasive's Simplify Disc has a significantly greater success rate at 24-month follow-up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR).
Findings from this study include:
Overall composite success...
Two-level FDA Investigational Device Exemption study data reiterates that NuVasive’s Simplify Disc has a significantly greater success rate at 24-month follow-up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR).
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, 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
Rate of subsequent surgical intervention was lower in the cTDR group compared to the ACDF group
Simplify is part of the NuVasive C360™ portfolio which offers procedurally integrated solutions for the anterior and posterior cervical spine, including ACDF, cTDR and posterior cervical fusion (PCF) procedures. Overall, the Simplify Disc demonstrates clinical superiority to ACDF and has the highest overall clinical success rate compared to any other approved cervical disc for two-level use.
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