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NuVasive (NUVA) Receives Conditional Approval from FDA to Begin Clinical Trial Enrollment for NeoDisc

June 28, 2006 9:39 AM EDT
NuVasive, Inc. (Nasdaq: NUVA) announced it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin clinical trial enrollment of its NeoDisc cervical disc replacement device.

The clinical trial is a prospective, randomized, controlled, multi-center trial to evaluate the safety and efficacy of NeoDisc by comparing the outcomes of patients to traditional anterior cervical discectomy and fusion. The Company expects to begin enrolling patients in the trial by the fourth quarter of 2006 with a follow-up period of two years.

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