Does anyone have any idea when the Maverick will get FDA approval, looking at the different discs , as I am planning on having the sugery very soon. The maverick seems to have the best right up as the metal on metal design did not show any wear in 31.5years of testing , and its design does not cause any extra load to the facet joints, this is far superior compared to the Charite or the prodisc which uses a polyethelene core which will wear , and the design will cause facet loading. Any information would be appreciated.

Do you have any links to the long term studies of the Maverick? I haven't seen the one about the 31.5 year test. The Maverick seems to be the best design on paper but the long term studies are important. I have also heard of 2 metals rubbing together "scoring" (sp?) and causing problems. I also heard the Maverick can't be used for multi-level because the keel can crack the vertebrae. Alot of us have to take what our insurance gives us. I waited a long time for this approval. I can't wait any longer for the Maverick. The combo of pain/drugs has driven me to a quicker decision. Prodisc is the industry standard right now so I am very happy to be (hopefully) getting a Prodisc in October.

So anyway, How 'bout that link buddy?

Thx & Good Luck!

The technical term for the most common type of metal-on-metal wear is galling. You can search on the web to find it's effects and tendency for various alloy and alloy combinations to gall.

Hummmm....I didn't think that there were any long-term studies out there like that on any of the ADRs really.

I thought that the longest in use was the Charite which is around 15 - perhaps approaching 20 years max of actual human implantation and follow up....

The study is an version of the following logic: An average person bends so often and so much as they live so if you take an ADR device and put it into a bend fixture and flex it to x degrees y times it simulates z period of time in a real person's back. You can see all of the assumptions that go into it, not to mention the degree to which the fixture simulates real movement greatly affects the quality of the test. As I mentioned in a different thread, these studies are great indicators but you'd be foolish to look at one device tested in one study for 25.684739372027 equivalent years and a second tested in a different study for 36.5743923173 equivalent years and decide one is really better than the other.

Hi,

Yes Anna is correct the 35.5 years is a simulated test in some kind of test rig. The web link where I found the info was www.centerforspinecare.com , FDA approval should be arounf mid 2007 , it looks like the best from a design point of view , but that could stand for nothing , until the FDA trials are complete ...lets see!! All I am concerned about is revisions , if the charite or prodisc wears out to soon. say 10 years , I will be back under the knife. Saying that Anna mantioned that the Charite testing data was 20+ years but in real life it only lasts 10 years , so I guess that says a lot about the accuracy of the testing figures.

Thanks for the first link.

Now...do you know anyone who has had a failed Charite after 10 years?

Link away my friend...

GALLING...THAT'S it! Thanx!

Good Stuff!

I dont know of anyone myself , but I have read that lots have failed and there are a few law suits out there.

James, can you reiterate on what you mean when you say, "lots have failed?"

I'm no champion of the Charite but the lawsuits are a VERY small percentage of the people implanted with the Charite.

Lots more have succeeded than failed. Somewhere between 83-93% success I think.
I'll take those odds from any bookie!

That is the exact opposite of my intention. Charite's have been in place in real people for about 10-20 yrs depending on which version (current is #3) you are talking about. That is the only real, hard, provable life figure you can cite. Studies show life out to 40 to 50 years for the same disk design. The same kinds of studies show equivalent life for the other disk designs but they haven't been in bodies for long enough to matter. There have been few Charite failure and, in my ignorance, I don't know of any life related failures at all. All of the failures where the core failed that I've heard of were implantation failures first leading to core damage.

Maybe I should not have used the word LOTS , but I have read about failures , relating to te core and movement due to the positioning of the spikes. Of course most of the people that have had the charite are very pleased and it shows good results. I am just only voicing my own concerns and should be taken with a pinch of salt, I am just stating information what I have read on the internet. If you say that the discs that have a plastic core last for 40 to 50 years then perfect , that is the information I was looking for. As I don't want to put something in my body that will not last!
Very interesting debate's on this site , its very enjoyable to get all this information with so many people willing to share there Knowledge.

Like yourself James, I'm looking at multi-level ADR as well.

I'm grateful that fusion is quickly becoming outdated. I do not think I will be able to wait it out for the next generation of prosthetic discs which use a coin-shaped bladder filled with a gel that is more disc-like than the current mechanical artificial discs. I'll most likely end up with Prodisc or if I can wait it out, Maverick.

After literature review, email correspondence with surgeons, review of posts on multiple sites, and my own reasoning ability, I've come to the conclusion that in my case, the Maverick is the way to go based on exactly the concerns you've presented in your original post. One day I might be envious of patients that have re-grown discs with stem cells, but given the timeliness of the options presented to me, I think if all goes well I could be happy, certainly much happier than I am now, should I find a US surgeon skilled enough to do multi-level ADR using Maverick on a previously fused spine.

I wish you well with your decision.

my .02 worth. My surgeon has been doing Charitte for about 12 years and says he has never had to replace one due to product failure. Only once due to someone who started weight training 3 weeks after her surgery. If i have to do this 10 years from now, thats okay by me. That being said i am only 40 now. It might be different if i was 10 years older.

Thats good news , I guess you always get a few horror stories , I am sure we should not really worry. Not sure how many times you could have revision surgery though due to scar tissue build up. Does anyone know about this that could help explain ??

Well, Ive got the Maverick and I'm happy enough with it so far though it's only been nearly 8 weeks. Actually, I feel more confident with the design and the keel, I can't imagine it ever subsiding! I would have been happy with any disc I think, the decision on which (charite or maverick) I was getting wasn't decided till I was in theatre and my spine had been assessed.
With my whole back being in a pretty crook state, my surgeon has already said there shouldn't be an issue if I need further surgery, he'll just go in on the opposite side (right) next time.
Hmmm, now that's a sobering thought (not!)
Cathy

Let's not forget about the Kineflex, which is metal. I've had mine for a year now and it's been great. My surgeon is a Maverick co-inventor, and he likes the Kineflex. It's still in FDA studies.

Matt, I agree with some of your points, disagree on others. Your point about trials for device companies is off – FDA trials are kept “airtight” for many reasons – and it is in the company’s interest to ensure this to endure FDA and public scrutiny. And device companies don’t think they will fail; otherwise they wouldn’t spend the millions!

And it is true that far more devices have succeeded than failed, though this forum is about sharing ALL the experiences: good, bad and the “average” outcomes in between.

Quantitative outcome data is the Holy Grail. Yes, the clinical trials provide data, but it is less than ideal in terms of its “readability,” let along availability. Next year, as a newly formed non-profit, I’ll be tackling this issue and launching a rigorous patient survey. More on this in the coming months.