fda there is no easy road, page-4

I find it totally unbelievable how Thoratec could make such a mistake.
Surely they must have agreed with the regulaters what was required of them for the submissions.
Thoratec have had their problems during the trials and they are second generation device.
Even though Thoratec deserve credit for being a trailblazer in these sort of devices....VCR are showing that they leave no stone upturned when it comes to liasing with the relavent authorities and even developing in tandem with the FDA innovative trial protocols...which in turn will speed things up for the Ventrassist to be commercialised.
I'm sure the FDA are well aware there will soon be a more advanced LVAD (and more technically superior product) soon to contend with...the ventrassist.
Second generation versus superior third generation LVAD and higher percentage survival rate.
VCR are making the right moves...getting everything in place for what should be a rapid transition from trial to commercialisation.
There's no doubt the Ventrassist will soon be the preffered transplant option in the world.