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Re: None

Wednesday, 01/11/2017 1:17:59 PM

Wednesday, January 11, 2017 1:17:59 PM

Post# of 10346
Some short on the yahoo board saying that a 40 patients trials done may not be enough for CE approval. Anyone have any input on other trials done for other medical devices for CE that were smaller trials ? ARCH showed safety and efficiency, so data wise they are good.
Thinking this is external bleeding, so a large trial (like needed for drugs, other non-medical devices, non-invasive etc.) are not really needed.
For internal bleeding, likely the patient size would be bit larger am guessing.