fda there is no easy road, page-5

I find it hard to believe Thoratec have made a mistake in this matter,when u consider that thoratec(the first generation)is the only device with FDA approval for DT Therapy.Thoratec 2 was given its CE mark in 2005 and wont get fda approval this year.To me things look very tough.I notice there is a similar size device as VCR called arrow Coraide does anyone know how they are going?they also have a CE mark