By Staff writer
An artificial spinal disc could offer an alternative to spinal fusion for patients with degenerated cervical discs, after securing a unanimous recommendation from an FDA advisory panel.
The Prestige spinal disc, produced by Medtronic, was deemed a safe and effective replacement by the panel, and recommended for FDA approval.
However, the group added that approval should be conditional upon further long-term studies.
Prestige is a two-part stainless steel device with a pivoting ball design to replace worn-out discs between neck vertebrae.
Unlike spinal fusion, which connects the two vertebrae surrounding a diseased disc, artificial discs aim to replace the natural disc and allow spinal movement.
If approved, Prestige would be the first artificial disc available for patients with degenerative disc disease affecting the cervical spine.
FDA panelists said the device proved to be only as good as, not better, than fusion.
“I do think this device has promise,” said FDA panelist Dr John Kirkpatrick, a University of Alabama orthopedic surgeon.
Still, several panelists expressed concern about the disc itself, questioning why Medtronic chose stainless steel instead of stronger cobalt and chrome used for other devices such as artificial hips.
“This is about as primitive an artificial disc device as one could conceive of or manufacture,” said panelist Dr Edward Hanley, an orthopedic surgeon from North Carolina.
“That may not make it bad. Simple may be good,” he added.
Medtronic officials said that, unlike other joints such as the hip, the upper spine does not
support much weight, and that data confirmed the device was strong enough for human use.
The company expects a final FDA decision by early 2007.