Medtronic Pioneers Artificial Cervical Disks

PRECISION TECHNOLOGY NEWS

Not only did Medtronic win FDA approval in July for the first artificial cervical disk on the U.S. market, but it also won backing from an advisory panel for a second such disk. That means by winter 2007, it could have two cervical disk products on the U.S. market before any other firm has one.

The Prestige, which won approval in July, and the Bryan, a second-generation product that could be approved this winter, treat cervical degenerative disk disease, which is a major cause of serious neck and arm pain. Both are made by the firm's Medtronic Sofamor Danek division.

The current standard of care for that condition in the United States is neck fusion. If a patient has a diseased or bulging disk in the neck, that disk is removed and two or more neck vertebrae are fused. This reduces range of motion. The Medtronic products replace the damaged disk and are attached to the adjacent vertebrae with bone screws, which may preserve range of motion. In principle, these products are an alternative to neck fusion in the same way that artificial spinal disks are an alternative to spinal fusion.

The firm will have to run postmarket safety studies on the Prestige as a condition of approval.

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