"I've obviously been skeptical about a getting Humanitarian Device Exemption and, drawing on my experience with the FDA, I still don't think that Canada accepting the DurAVR into its Special Access Program will have any bearing on an FDA decision about whether ViV is an unmet condition or not. I'd love to be proven wrong but that's my opinion. "
If there is a real alternative, what is it? Obviously the Canadian authorities do not believe the current incumbents of Sapien or Evolut to be alternative even in an 84year old.
Ann: DurAVR first successful implantation Valve-in-Valve, page-12
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