NuVasive asks FDA to allow trial of NeoDisc

New York, Oct. 24 - NuVasive, Inc. said it has asked the Food and Drug Administration to give it an Investigational Device Exemption so that it can carry out a human clinical study in the United States on its NeoDisc product.

The study would investigate the device's safety and effectiveness.

NeoDisc is a "nucleus-like replacement device" designed to preserve motion in the cervical region of the spine, filling the gap between pre-surgical treatment and total disc replacement or spinal fusion, the company said. NuVasive added that it believes the NeoDisc will be attractive because it is easily revisable and is intended to involve a relatively simple surgical placement procedure.

"We believe that if FDA approval is obtained, the NeoDisc device, coupled with our Cerpass TDR [Total Disc Replacement] product in development, could provide us with a comprehensive offering for the preservation of motion for the cervical spine," said Alexis V. Lukianov, NuVasive's chairman and chief executive officer, in a news release.

NuVasive is a San Diego-based medical device company focused on developing products for minimally disruptive surgical treatments for the spine.

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