A key Advisory Panel of the Food and Drug Administration (FDA) has recommend approval for an artificial cervical intervertebral disc device. The panel’s recommendations were based on results of limited clinical trials and the FDA is likely to approve the device for use in patients.
While artificial discs have been used in UK and Europe for many years, this will be the first artificial cervical disc approved for use in patients in the US. Artificial discs by other manufacturers are also at various stages of clinical trials and are in the process of seeking FDA approval.
Healthy spinal discs are soft but tough shock absorbers that separate each vertebral body making up the spine. Discs allow the spine to bend and twist. As we age, discs begin to dry out and lose their ability to absorb shocks, resulting in their bulging. This can put pressure on the spinal cord and nerves, leading to neck or arm pain.
In current surgical practice, the degenerated disc is removed and adjacent vertebrae are fused together with a metal plate, aiming to lessen the pain. But it also prevents natural movement of the spine, putting additional stresses on the adjacent (healthy) non-fused discs, quickening their breakdown and possibly leading to additional surgery.
The new artificial discs will be placed between the two vertebral bodies after the affected disc has been removed. Ideally, the artificial disc acts much like a human disk, providing flexible motion while acting as a shock absorber in the spine.
As part of the approval, the FDA panel has also insisted that the manufacturer Medtronic Sofamor Danek, Minneapolis, MN, conduct additional clinical studies to determine the long term durability of this device. This process will provide an early warning of complications and unexpected problems in a larger patient population.
“Surgeons here at the Orthopaedic Spine Center at MGH will be involved in the use and study of artificial cervical discs in the months to come,” reports Dr Kirkham Wood MD, Chief of the Orthopaedic Spine Service at MGH, and Assistant Professor of Orthopaedic Surgery at Harvard Medical School.