6 Things to Know About Cervical Artificial Discs

In mid-July, the FDA gave final approval for Medtronic to make the first ever cervical artificial disc commercially available in the U.S.: the Prestige Cervical Disc.

The Prestige Cervical Disc is an artificial disc used to replace a problematic disc in patients with single-level (meaning only one spinal disc is affected) cervical degenerative disc disease. Disc degeneration is a normal part of aging, but painful degeneration is caused by a fall, a twisting injury or repetitive wear-and-tear to the cervical spine. Symptoms of cervical degenerative disc disease include low-grade pain from a stiff or inflexible neck and numbness, tingling, or weakness in the neck, arms, or shoulders as a result of nerves in the cervical area becoming irritated or pinched. Cervical fusion surgery is the current gold standard treatment for cervical degenerative disc disease.

So, what do you need to know? A few things:

1. In general, surgery for neck pain is much less reliable than surgery to relieve arm pain from cervical degenerative disc disease. Thus, if the only or predominant symptom is neck pain, surgery should be recommended only as a last resort or even avoided altogether.
2. Not all patients who are candidates for cervical fusion surgery are candidates for cervical artificial disc replacement.
3. Although the Prestige is already in use in Europe, the U.S. clinical study was conducted on 541 people. As a condition of FDA approval, Medtronic must conduct a seven-year study of the device’s long-term safety and effectiveness. One of the big questions with artificial discs, both lumbar and cervical, is just how long the device will last.
4. The Prestige Cervical Disc was found by the FDA to be as safe and effective as cervical fusion, not more so. The theoretical advantages of discs over fusion include quicker post-op recovery and more flexibility in the neck, but the FDA panel said the results weren’t strong enough to support a superiority claim.
5. Cost for artificial disc surgery with the Prestige is expected to be about the same as for a cervical fusion – in the $30,000-$35,000 range. Fusion surgery generally enjoys good insurance coverage, while artificial disc replacement coverage, so far only lumbar, has been inconsistent.
6. The day after the FDA approved the Prestige, Medtronic’s Bryan cervical disc received a recommendation for approval by the FDA (potentially available Winter ‘07). The Bryan is said to more closely resemble a natural spinal disk than the Prestige and could emerge for use in multiple disk replacements at some point in the future. There are also several other cervical discs being studied which may be approved in the next several years.

Artificial discs are a new and potentially exciting alternative for people with pain and disability from cervical degenerative disc disease. However, patients should proceed with caution, especially this early in the game, and be armed with as much information as possible before making a decision about surgery for arm pain and/or neck pain.

Posted by: Sylvia