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.
All procedures do help to build evidence that the DurAVR is safe and effective and the success of this implantation may help to get ViV added to a trial, potentially the EFS, if that's something the FDA is wavering on.
This really is fantastic news all around, especially being able to restore a patient in such a dire condition to near normal flow. It's truly amazing and is a huge step for the company, all of us invested and patients who desperately need a next gen device. I'm very happy to be a small part of this.
Ann: DurAVR first successful implantation Valve-in-Valve, page-10
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