FDA Post-approval Study: Long-term Safety and Effectiveness of the ProDisc-L Total Disc Replacement

[Justin]

Below, is the Long-term Study Schedule for the ProDisc-L from the FDA's website:

[Gilbert P]

Hi Justin

O.K. Now what?

I could not log on.

Is their any really long term results on ADR like 20 years or any speculation on results?

Thanks

Gilbert P

[Liz]

i'm not really sure what this means either... justin, do you have a paper from the FDA on these results? it's also only 2 years.

take care,
liz

[Justin]

i'm not really sure what this means either... justin, do you have a paper from the FDA on these results? it's also only 2 years.

take care,
liz

Hey Liz,

The significance of these dates are, in my opinion, key for more acceptance / approval by insurance companies. The ProDisc-L was approved by the FDA on August 14, 2006. These study dates are post-approval follow-up, which will help make or break the case for artificial disc replacement in terms of "long-term" efficacy (there is also multilevel data coming out). I believe the ProDisc-L study began in 2004 (I need to check on this)--don't forget to add the clinical trial duration to the post-approval follow-ups.

Many insurance companies are not currently covering artificial disc replacement on lack of "long-term data;" they have changed their tune from "investigational."

The final report in 2010 will hopefully provide data that will ultimately help Spine Patients and widen insurance coverage.