Considering Hybrid, hopefully with Freedom Disc

[Texas Toast]

Ok, so I'm considering a hybrid with fusion at S1/L5 and ADR at L5/L4. I think the FDA has approved the ProDisc and Charite for lumbar.

1) Does this mean I can only get the ProDisc or Charite with lumbar fusion?

2) Also, does the FDA require separate clinical trials for the hybrid procedure?

3) I saw on clinicaltrials.gov (Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease - Full Text View - ClinicalTrials.gov) that the Freedom Disc trials (single-level) began in Sept 2008. Does that mean that the Freedom may be approved 4 years later in Sept 2012? Trying to figure out how long I'd have to wait.

4) The Freedom Disc trial I mentioned in question 3 above is for single-level, though. Will that trial be enough for approval to use Freedom with hybrid surgery? Or will a new trial likely begin after Sept 2012 to test the Freedom Disc with hybrid surgery?

Thanks everyone

[Jstuckey]

Here's a quick answer that others may get more technical on:
Question 1: Those are the only 2 FDA approved, although others are available if you qualify for a clinical trial.
Question 2: My insurance company required separate trials. They said that the approved use per FDA guidelines is single level degeneration, therefore my multiple level degeneration (and needing a hybrid or 2 level ADR) was outside of the approved use.... AKA denied.
Question 3 and 4 - I wouldn't bank on either.

Spending your own money is no fun (or in my case... a hefty loan), but don't count out that possibility. I wouldn't trade what I got 4 weeks ago for anything ....not even an insurance-approved hybrid right here at home. It took me a long time to reach that point, though, and everyone has different medical needs. Keep researching and get lots of opinions to find your right mix. For me, the insurance denial was just the start....

[Texas Toast]

JSTUCKEY, Thanks for the note and for sharing about your experience. This is very helpful. I also saw your blog mentioned in your signature and am checking that out as well.

I'm trying to get on Social Security and Medicare but it looks doubtful that they will pay for a hybrid. Since I'm unemployed and cannot work anyway, I doubt a bank would loan me $40K.

[laid up doc]

i don't know of any insurance that covers hybrids in the US - my ADR friendly and fusion nonfriendly insurance doesn't cover hybrids at all.

you are probably looking at a 2 level fusion if you are going to be under medicaid, if anything. not trying to be negative, just realistic... and i hope you live in a state w/ good medicaid so you can see a decent surgeon. if not... honestly, i'd move.

[Texas Toast]

Hey, I found this article from Feb 2011. It says the Freedom disc (somewhat like the M6) received it's CE Mark in Europe and needs two more years of followup in the U.S. before they can apply for a PMA (pre-market approval) with the FDA, which I ASSUME means it would be "FDA approved."

Does this could mean the Freedom disc might be available in Feb 2013? I don't know if I can wait that long. Article also says a Cervical Freedom Disc is on the way, too. The article is on p. 8 of Biomedical Business and Technology.

The link is http://www.bioenterprise.com/images/...b2011_5a82.PDF
Also, I pasted the article below:


• AxioMed Spine (Garfield Heights, Ohio) develops devices designed for restoring function to patients
who have symptomatic degenerative spine disease.
The company’s Freedom lumbar disc is the first onepiece elastomeric total disc replacement. It is based on
an invention of surgeons at the Cleveland Clinic and is
cleared under an IDE for ongoing clinical trials randomized against the ProDisc-L from Synthes Spine (West
Chester, Pennsylvania). The Freedom one-piece design
utilizes a proprietary metal-polymer bonding technology. The company has an exclusive license for the CarboSil polymer, a proprietary polymer that is supplied by
the Polymer Technology Group (Berkeley, California),
a subsidiary of DSM Biomedical (Geleen, the Netherlands). The Freedom lumbar disc has the CE mark and
is being marketed in the UK, Germany and Switzerland.
In the U.S., the company needs a 2-year follow up before
filing for a PMA with the FDA. AxioMed is developing
the Freedom cervical disc that is more anatomically correct in fit and function than existing commercial cervical
discs. Both devices incorporate titanium endplates and
their viscoelastic mechanical properties mimic the natural disc. It plans to file for the CE mark in the fall of 2011
for the Freedom cervical disc.