The FDA Approves Charite Disc Arthoplasty
BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004
Hats off to DePuy Spine for winding this approval through the FDA so masterfully. The timing (to coincide with NASS) was exactly right. The website is excellent and we repeat some key points from it later in this commentary. Future disc arthroplasty companies can learn from this model. Now, of course, how to pay for it. But, in the glow of this approval, DePuy Spine deserves high fives all around.
Certainly, with as much as $400 million at stake (purchase price plus clinical trial and marketing expenses), the pressure is on at DePuy to drive a rapid uptake. But this is clearly not the tone or message on its web site or in the literature. At rare times, the opportunity to dominate a market segment presents itself. But if that means rising risk of patient complications due to learning curve issues, then the ethical question is engaged. Do you dominate or do you lead? From its literature and from conversations with their surgeon champions, the answer is obvious. This firm is taking the natural course for a leader, the high road.
Our readers can see this for themselves. Here is the language from the DePuy website:
'As a last resort, and only if all other conservative treatments fail, surgery might be considered.
While the use of an artificial disc is considered to be an extremely effective option for patients with degenerative disc disease, this technology is not appropriate for everyone. The CHARIT…ô Artificial Disc should not be used if:
- you have either an infection throughout your body or localized to your spine; or,
- you have disc deterioration or instability at more than one spinal level; or,
- if you have poor bone quality (osteoporosis or osteopenia).
Your occupation or activity levels, your weight, the condition of other levels of your spine, whether or not you are pregnant, and any allergies you have may influence whether you should have surgery with the CHARIT…ô Artificial Disc. If any of these factors apply to you, please discuss them with your doctor.'
When is conventional wisdom wrong? We've written about the problems of the learning curve with the Charite. We've written about the long history in Europe and the rather lukewarm attitude there towards the Charite. One surgeon who'd performed several hundred Charite implants stated that it was probably applicable to only 5% of his patients. And there are the infamous training patients that imply that this device and this procedure will need to be approached very carefully by both patients and surgeons.
As we made our way around NASS last week, the conventional wisdom among rank and file surgeons we talked to was exactly that, to be very careful with regards to Charite and to approach both patient selection and training with, if anything, exaggerated respect.
Apparently DePuy agrees. If everyone is being careful and thoughtful, then who will be left to be irrationally exuberant about this new device and technique? And if the manufacturer is writing and saying things like the quote we used above, then maybe the fears of a new cage rage are themselves exaggerated.
We noted that one of the most widely read websites in spine, Spine-Health (three million hits a month) is repeating the conventional wisdom so we know the message is getting into the fabric of the patient and surgeon communities.
Bottom line, we think it is possible that this roll out well be smoother and less fraught with complication than we and the conventional wisdom originally expected.
What does that mean for patients? Better selection, better surgeries and ultimately, satisfaction rates that meet and, potentially, beat standard fusion.
