Charite Artificial Intervertebral Discs--ready for prime time?
Posted by Clark Venable on 12/26/2004
DePuy Spine/J&J are marketing Charite artificial discs as an alternative to spinal fusion. A recent New York Times report, though pointing out that long term evidence is lacking, was basically positive and contained the following quote from a company representative:
Some of the anecdotal evidence? What? This device has been in use in Europe for two decades and that's the best they can do? The Charite web site with information for physicians has results but no references. None.
The one study I did find via PubMed concluded:
It may be a 'viable alternative', but there's no data on long term results. Here's what I bet will happen. The FDA will approve the device and ask for long term followup, which is actually done by a company in fewer than half the cases where it is requested by the FDA. (I don't know J&J's record specifically, though.) Patients will read about it and find a surgeon that does the Charite procedure (even if it means going to someone who is not their normal orthopedic surgeon)...and resort to the legal system if their expectations are not met or their long term results are disappointing.
[Via Medgadget]
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