ProDisc-C now FDA approved!

mmglobal · #1 (**permalink**) 12-21-2007, 12:25 AM

I'm back in the US now, and arrived home to wonderful news. Tuesday, Synthes received FDA approval for ProDisc-C!

From Synthes website... here is news item.

Hopefully, we'll see insurance reimbursement issues resolved faster for cervical ADR than the horrible lack of progress we've seen for lumbar.

Mark

dshobbies · #2 (**permalink**) 12-21-2007, 10:20 PM

Unrelated to ADRs but turned down for the same reason, Cigna recently refused a liver transplant for a 17 year old Leukemia victim. It was her only chance for life yet they still called it experimental. An uproar ensued, the doctores wrote letters, a press conference was held. Public support expressed outrage until Cigna recanted and approved the liver transplant. Unfortunately, this poor 17 year old girl died last night, just hours after the approval.

Cigna is now being sued civily by this poor girl's family and consideration for criminal prosecution, from manslaughter to murder, is also being considered.

Our lives may not be in jeopardy but our mental and emotional ones most certainly are, not to mention the effects on our families. My blood is currently boiling

. I can't even express my anger with insurance companies with their 'experimental' rational. So many of us took second trust deeds out on our homes (thank you especially California) willing to spend our own hard earned money and/or forgo other expenses to find the relief we so sought... while our insurance companies clung to every penny, practicing their own brand of cost factor medicine, caring not an ounce for anyone's suffering. Spitting is of no value but I'm beginning to understand other motives for strangulation.

I hope they hang the sob's. (pardon my languange)

sahuaro · #3 (**permalink**) 12-22-2007, 01:43 AM

I am in the midst of writing an appeal for cervical ADR, which will end up being longer than my doctoral dissertation. Perhaps I'm just in a bad mood, but I don't think the approval of ProDisc-C is going to make a difference, at least not in the near future.

According to an article I read, the poor leukemia victim's lawyer is asking to have charges filed against Cigna for manslaughter. It's about time.

mmglobal · #4 (**permalink**) 12-22-2007, 04:11 AM

For those with multiple level cervical disease, ProDisc-C provides an option that does not have the drawbacks of the PrestigeST, which cannot be implanted at adjacent levels. The only other cervical ADR's available in the US, outside of clinical trials at this time are the Bryan disc and Prestige ST.

The Bryan disc has many issues with a very complex and error-prone implantation technique and potential HO resulting from extensive milling required.

I think that the earlier than expected approval of ProDisc-C does change things for people looking at cervical ADR.

Mark

PS... sorry, I owe you an email.

nopain · #5 (**permalink**) 06-06-2008, 06:55 AM

Mobi-C is in clinical trial in the USA and is used for multiple levels as well I understand.

I know there is no one best solution and Dr. Experience with the methods used to implant these devices is still early, but I have a question I hope someone can answer.

If a disc has collapsed so much that it's almost gone, but the bone has not fused together naturally, can any of these devices still be implanted with success?

I know in the clinical trials for the Prestige having disc space was one of the criteria.

Is a person with a collapsed disc automatically a "Bad Candidate"?