FDAnews Device Daily Bulletin

NUVASIVE GETS CONDITIONAL APPROVAL FOR NEODISC TRIAL

June 30, 2006
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NuVasive has received conditional approval of an investigational device exemption (IDE) from the FDA to begin clinical trial enrollment of its NeoDisc cervical disc replacement device.

The clinical trial is a prospective, randomized, controlled, multicenter 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.

The most common form of surgery for treating cervical degenerative disc disease is cervical spinal fusion, which is intended to relieve an impingement on the spinal cord or nerve root and relieve associated arm and/or neck pain. In a cervical spine fusion procedure, the degenerated disc is removed, an interbody implant is inserted in its place, and a metal plate is then implanted to fuse the cervical vertebrae together.

NeoDisc is designed to treat patients earlier in the degenerative cascade, prior to a fusion procedure, and to be imaging-friendly (radiolucent) and fully revisable. It is designed to safely replace a degenerative cervical disc nucleus, partial annulus and anterior longitudinal ligament, while maintaining range of motion and leaving the natural vertebral endplates intact.