I wish I knew more about Canada but I've done a good bit of...

I wish I knew more about Canada but I've done a good bit of research and I can't find any info on what it would take to get a ViV approval. It seems logical that we would need a general approval first, though. Could we just get an approval after a small ViV study? I don't know but I really doubt it without completing the large study first.

In the US, the Sapien got a specific ViV addition to their approval based off of 314 TAVR ViV procedures that had been done under the general approval. So once the Sapien received the general Premarket Approva in 2011, doctors could use the device for valve-in-valve but it was not specified in the devices' approved information and instructions. The device then got ViV approval in 2017 as a result of those 314 procedures that had been done over the years under the general approval. It wasn't a separate study. The key is that you need the general approval first then use ViV data, whether from a separate study or just a retrospective analysis of commericial ViV use, to get the expanded approval, which really just makes doctors more comfortable with the device and may affect reimbursement and how hospitals treat liability.

And w_i_z_z_a, the important thing with the Breakthrough Device designation is that it speeds up interactions with the FDA but likely won't lessen the amount of patients we need for the trial. With ViV maybe it could potentially increase our chances of getting a Humanitarian Device Exemption, which would allow the sale of up to 8,000 devices per year for profit while we are still in trials, but that would still need a large enough trial for ViV to prove safety, which may defeat the purpose of trying to go down that pathway. And I'm very skeptical that we can get an HDE with other devices currently commercially approved for ViV. A Breakthrough designation is always a good thing, though, and is much easier to get with devices than drugs.