M-6 ?

[Gilbert P]

Does anyone know or have more information on the M-6 disc. It seems to have lots of parts and very new.

I know Stenum uses this disc and the Maverick is out due to patten law suites.

I also could not find any clinical trials in the U.S.

I think the M-6 came out in 2008 with little use? not sure.

Looks promising but they all do

Thanks

Gil

[trkdoc714]

Spinal Kinetics

Here's Spinal Kinetics' link Gil.

Also, I think there are plenty of Mavericks available. I asked that question of availability last year. I was told there are thousands of them on the shelf. If I'm not mistaken, Medtronic can produce and sell them, they just have to pay Synthes a percentage.

Bob

[JK2234]

They did have some clinical trials in the U.S. for the M6. I tried to get in one, let me look it up and see if i can find a link.

[trkdoc714]

I'm not sure if Gil would qualify for a trial. He has too many levels affected. That was the same reason that kept me out of a trial. The discectomy/ laminectomy also excludes trial candidates.

[tyler]

Does anyone know or have more information on the M-6 disc. It seems to have lots of parts and very new.

I know Stenum uses this disc and the Maverick is out due to patten law suites.

I also could not find any clinical trials in the U.S.

I think the M-6 came out in 2008 with little use? not sure.

Looks promising but they all do

Thanks

Gil

Hi Gil,

There's a lot of use of M6 but in Europe - as with most ADRs. They've done a clinical study in the U.S. but would have to do another one for marketing approval here. Also Synthes (the ProDisc folks) have sued Spinal Kinetics (over M6) as well as Medtronic (over Maverick) in an effort to keep newer competitors out of the U.S. market. But almost half of Americans getting ADRs are going to Europe anyway (myself included) because even ProDisc 2-level is considered off-label by FDA - so apparently Spinal Kinetics is initially focusing on expanding markets in Europe and elsewhere. As far as Maverick, since there's been a judgment against Medtronic - and they manufacture and export Maverick from the U.S. - they can't even supply new discs into Europe but are apparently considering moving manufacture out of the States.

Here's some more technical information on M6:
Spinal Kinetics M6 - A Shock-absorbing Artificial Disc with "Graded Resistance"

I just had mine installed and couldn't be happier with the results:
Relief After Cervical ADR C5-6 & C6-7 with Spinal Kinetics M6-C Artifical Disc / Nick Boeree, Nuffield Wessex

If I can be of any further help let me know!

Best,
Tyler

[cragar59]

I just signed on and hope this thread will reach Tyler and others with cervical situations, as they better relate to my C3-C7 mess. I must say that I am amazed at the amount of damage to most of you. It grieves me further to see that a lot of it was not your fault. Anyway, I suppose I have no one to blame but myself for my condition.

According to the radiology report from a recent CT scan I have severe disc degeneration from level C3 to C7, with nerve impingement from bone spurs and canal restriction. I have been searching for as many opinions and estimates I can find to make a decision (like all of you) and unfortunately they vary too much to be confident.

Recommendations vary from: 4 level ADR, 3 level ADR/1 level fusion, or 1 level ADR/3 level fusion. Isn't fusion old school? I have received estimates from various locations in India & Germany and am awaiting others from Spain, England, Mexico, and Thailand. It looks like Bergtnoli (sic) is best, then Ritter-Lang, but India's Fortis is the best price so far. Chavel (sic) in Spain, Germany, and UK use the M6 and India uses the other types. I would like to read good and bad from patients of all surgeons and devices.

From what I see of the device design, I am impressed by Spinal Kinetics M6 and Axio Med polymer core compositions. Dr. Hegde in India uses the ProDisc C or Prestige LP, which I do not like, but I see the new PDC Nova has two shorter upper retainers instead of one large keel. The invasive type plates with ADR and screws in fusion appear to me to compromise the vertebrae, especially in multi-level procedures.

Tyler, I was told the M6 is too flexible for multilevel, but I think it replicates the natural disc best. Please stay in touch with your post op condition. It was a month ago, correct? Looking forward to reading about selections and conditions from all of you. God bless!

[tyler]

Tyler, I was told the M6 is too flexible for multilevel, but I think it replicates the natural disc best. Please stay in touch with your post op condition. It was a month ago, correct?

Hi Craig,

I just replied on your thread as well, here are some thoughts that might help you raise issues further with the docs you're consulting:

As far as multiple implants, it would seem that the potential 'flexibility' issue could be greater for discs that allow more free movement - typically referred to as unconstrained or less constrained discs.

My understanding is that ProDisc, which has been used in multiple levels (although not FDA approved for multilevel since the trials were 1-level), is considered 'semi-constrained.' Basically it's less constrained than the native discs in some directions, e.g. turning, and more constrained in others.

As for multiple implants of M6 (also not FDA approved but used in Europe), I didn't hear any substantial concerns about it with the docs I consulted - and several of us (including Jeff, Marti and myself) have all had multiple M6s implanted.

While M6 can bend in all of the natural directions, it actually has some resistance to pull - just like the native disc - because the fibers making up the annulus start to resist further extension the more they're stretched (this is referred to as 'graded resistance'). Same with compressibility, it has some but is not soft or floating by any means.

It was pretty cool to feel these motions with the actual discs that my surgeon Nick Boeree let me play with (pics in my photo album). It's not at all like a spring, much more like compressing or turning a fixed piece of tire tread - you can do it, and it does absorb shocks/stresses, but it's also resistant to turning and compression as you push it more, which is why it works as it does. Again the discs were basically designed to match the originals.

I would raise these issues with the docs you're talking to. It does sound like you're making progress, and hopefully will be well guided into what works best for you. There are also situations that some docs believe favor hybrids (i.e. discs and fusions), which many people have also had.

In your case, are the multiple discs you referred to all severely affected? And what about the arm pain and weakness - does it appear to line up with images? I can say that mine was fairly clearcut - in fact several of the docs more or less said that from my pain/weakness pattern they could have basically drawn the MRIs.

By the way, Friday will mark 4 weeks since surgery - and I've been completely off pain meds since the second day post-op, which I never would have imagined.

Please let me know if I can help further in any way. And in the meantime wishing you the best!
Tyler