Mark,
I'm trying to wrap my mind around criterion 4 & 5... The numbers in the studies I have read proved to be as beneficial as the "golden standard" of fusion.
I'm not sure what they mean that improvement must be obtainable outside the clinical study. My impression is that there must be some sort of measurable improvement of the patient population after the 2 year study is completed???
I'll think it through a bit more...
Have fun at the concert.
Poncho
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