My conversations with LDR Spine and the FDA

Hi all,

As some of you know, I've been desperately trying to get info on the Mobi-C cervical disc, which my NS would use if I elect to have surgery with him.

LDR Spine, maker of the Mobi-C, has a base in the US and one in France. They received FDA approval in February to conduct clinical trials in the US due to 'very promising results' in the 350 implantations outside the US. Patient selection is still underway to my knowledge. Yet aside from that tidbit of info, there is no concrete data on these first 350 patients.

I contacted a representative of LDR Spine USA and asked for both this information, and some conceptual explanations on the mobile 'self-centering' core of the Mobi-C, which again to my knowledge is the only one on the market like this. I explained that here in France, I can't find what I need in order to make an informed decision on my surgery.

Got a very nice email back saying they'd contacted their French colleagues, and that this information was available 'upon simple request'. The person who emailed me said not to hesitate if I had trouble obtaining it (this was last week).

So, I contacted (phone and email) LDR spine on this side of the puddle--got a response saying 'sorry, we can't give you any more info than what's on our website but the data really is very promising so trust your surgeon'. I wrote back basically saying--nicely, I promise--'you've got to be kidding yadda yadda yadda and please understand my need as a patient for more specific information on your part, please help' (trying to keep it short and sweet, folks!). No reply.

So I translated and forwarded these emails to my US contact, the one who said 'let me know if you can't get the info' and said' I can't get the info, please help'---and no further reply there either.

So, spoke to my NS today. He said 'hang on, I will call LDR Spine myself and get back to you'. Fifteen minutes later the phone rang and he gave me another name and a phone number, and said that the gentleman was waiting for my call and would answer my questions, but that the 'official data won't be released for at least a few more weeks'. I haven't called him yet; it was too late by the time I finished with my two 30-minute conversations with my NS.

My NS did say he was glad he called, because he came away with two tidbits of info out of LDR Spine that he'll be able to give to future ADR patients: the Mobi-C in vivo tests showed that after 11,500,000 cycles of movement (the equivalent of 40 years, as a cervical year is estimated at 350,000 cycles), the core of the disc had barely diminished by one-tenth. Mathematically this granted the Mobi-C a theoretical potential of anywhere from 40 years (already considered pretty good)to 600 years.

Boy, think what Moses could have done with a Mobi-C....

Anyway--decided to give the FDA a shot, seeing as they'd approved clinical trials. So I called and got a very nice man who told me that no, he was sorry, but he could not give me access to the FDA approval report for clinical trials onthe Mobi-C until LDR Spine released the information themselves, as it would be illegal (professional secret laws).

When I asked about the patients' rights to be informed about the product before they agree to clinical trials, he responded that each potential patient would receive and sign a 'patient consent form' outlining the risks of the procedure as well as potential benefits, but that the in vivo and preliminary data on the first implantations was information strictly belonging to LDR, to give or with hold at will. Until they talk about it, the FDA won't.

Trying to figure out how in the hack we patients are protected--or respected!--in the least here.

That's all I got for now. Will call this LDR Spine guy tomorrow with a list of questions. If any cervies out there want me to ask anything specific, PM me tonight (6 hours time difference between France and the east coast USA) and I will gladly integrate them...

Time for FOOD. A bit burned out here.

Trace