Maverick Approval

[Corry]

Well, I'm sitting here trying to do some more research on this, and learning much more than I wanted to about how to get a device approved

Anyhow, I got a question I hope someone can provide a definitive answer on. What is the difference between the Maverick and the A-Mav? Now, I thought it was the A-Mav had a smaller keel thus was usefull for multiple levels w/o worry of cracking vertebrae.

I got to this question because of the following 2 pages:

http://clinicaltrials.gov/ct2/show/NCT00635934 and
http://clinicaltrials.gov/ct2/show/N...0635843&rank=1

A little ways down the page you see the Enrollment, Study start date, and study end date. The maverick, which, my understanding was the older device, and in fact, has an older start date, doesnt have a study that ends till 2011, where as the A-Mav ends February 2009.

I came to this trying to see if I can just infer when to expect approval, I guess for the A-Mav since that is what I would likely need

I'm not sure on this, can the FDA rule before the end of the study, or am I SOL until at least Feb 2009? I assume since there was tons of chatter last year about it getting approved before the end of the year it can be approved before the official end of the study.

That said, I'm trying to see if I can find the PMA form anywhere online for the A-Mav and/or the Maverick. The reason is I looked at the recent approvals page, and the last date stamped on the most recent approval was September 2007. I seem to remember hearing that the Maverick/A-Mav went in about October 2007. It looks like the FDA therefore is about a year behind. Go figure....and to American's want US Government run Health Insurance, what a joke that would be (I am all for health insurance for everyone, just not through the US gov't BTW )

My assumption is that the meeeting scheduled for December 8-9 is for the Maverick/A-Mav, but I'm trying to see if I can find further reason to validate this idea (hope)

Anyone done any legwork on any of this already?

[OsteoRach]

from what i understand you are correct, the A-Mav is the newer Maverick although in all my research i struggled to find much information on the differences. Medtronic are also trialling the O-Mav which has an oblique placement, the results however seemed not as promising as the A-Mav. Apparently the O-Mav is harder to place correctly.

[Terry]

I have two Maverick discs in my lumbar area. I am thrilled with the outcome though I am unsure of the ability to ski due to the potential to fall and land on my tailbone. I am nervous about the potential to crack the vertebrae from the impact.

So you are in a good position to get the latest and greatest with the smaller keel. With your young age, and propensity to act like Superman, you will need a heavy duty device.

I just hope it gets approved at a time when it will be beneficial for you. The government moves slow.

Hang in there.

Terry Newton

[Corry]

Yeah, I know the A-Mav suits me, so I'm trying to figure out what I'm looking for on the FDA's site since they are so tight lipped.
I know this is a bad thing to post, but I work in defense. You know certain people have clearances, and have worked certain projects. When you find person A and person B are now working on some new project AB, you have a pretty good idea of what project AB is. This is of course considered privilaged information and follows the same rules as if you were read in on the project. You don't go talking about what project AB is to anyone. With the FDA however, there isn't a security clearance involved, so trying to take piece of information A and piece of information B to infer item AB, say, the approximate approval of the A-Mav disk, is perfectly legal Which is what I'm trying to do.

Thus, I looked at the study, and was concered the A-Mav ends Feb 2009...does this mean the FDA will wait till then to rule? Hmmm I suppose I should check on the studies from the prodisc and charite, see if they are ongoing (but its too late to do so now, I'm soooooo incrediblty tired from this past week.)

If it can be approved before the end of they study, then I need to know when Medtronic put in the PMA. It seems like the FDA has a backlog of about 1 year. I seem to remember something October 2007 saying this was filed, but I can't seem to find anything on that now.

Assuming I'm not nuts, and they did file 10/2007, and the FDA has a 1 year backlog that means the earliest approval would be October 2008. Then, how long do they take to read everything over on a study like this? I assume this is a bigger decision than most that I saw immediatly listed. Say it takes 1.5-2 months, that puts us right in the December 2008 timeframe, when CDRH Orthopedics is meeting.

Thats a lot of assumptions I'd like to confirm, or fit real numbers to so I can infer when approximatly the device will be approved...

If anyone has any of the above info, please share

[Justin]

Hey Corry,

The FDA IDE trial of the Charite started the randomized enrollment arm of the study in May 2000 and finished this arm in 2002. However, before the randomized arm started each site was required to do five non-randomized cases (a total of 71 non-randomized cases, which were not included in the study results).

Anyway, after extensive review by the FDA the Charite was awarded approval 2 years later in October of 2004.

I hope this helps give you an idea of the FDA timing. Hang in there…
-Justin