Hey @MacTavishNat, that link looks like the same info from my original post. No update since the 26th of Sep — HotCopper posters just took a bit longer to find it.

You’re right, it is more than initially indicated. I’d say this has been part of the FDA feedback during the IDE process. I think a factor is the head-to-head to standard of care component. So for every new implant with DurAVR is matched with a Sapien or Evolut. So if there were a 1000 patients only 500 would get DurAVR, so a smaller sample.

Valve-in-Valve will be exclusively DurAVR for the study.

I don’t think ViV is going to be any quicker to market — at least in the US. Anteris was initially musing about a separate pathway, a Humanitarian Device Exemption (HDE) instead of a IDE, but has given up on that. Europe might be different. We’ll have to see. But to me it looks like from what little we know about the PARADIGM trial so far both initial AS and ViV will reaching commercial approval from FDA (if granted) around the same time.

And the the SEC filing (ASX announcement likely to follow this morning):

https://www.sec.gov/Archives/edgar/data/2011514/000114036125036430/ef20054947_8k.htm

Official confirmation IDE was subject of further FDA requests and not yet issued. Trial now due to commence Q4.