The reason why VCR is going into Europe first is because they tend to be easier to deal with as far as regulations is concerned. It doesn't take so much time to get approval.
However, once approval of the FDA is obtained there is nothing to stop VCR selling their LVADS there and they are already have the contacts there.
The US has approval to sell their LVADS in Europe. Obviously, the US can't keep the European or Australian devices out.
Gerry
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