Sarge
I think you have completely misread the paragraphs relating to safety.
The safety profile of the device is very sound.
No SAEs related to the device or the EUS procedure.
Let’s agree to disagree and see how others have read that statement.
And ultimately when the CE Mark is provided the discussion about will be a mute point.
Hopefully you are on board by then.
Feels like Ground Hog Day......another New Year, page-35
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