Comparing what Anteris will have to do with what Medtronic and Edwards had to do is folly. They are not comparable. When Edwards did their first trials in the USA they had to stop due to high deaths and change the delivery method. It was far from a proven technology.
Fast forward more than 10 years and TAVR is not experimental anymore. Further to this the main component of the DurAVR has already been implanted in 20k patients and Adapt is already FDA approved.
Add to that the prospects of us getting Breakthrough Device and the perks that come to that and we could have an accelerated pathway to commercialisation.
So again trying to gauge what we may need to do in terms of patient numbers etc comparing us to the trials of Edwards and Medtronics may not be accurate.
Just IMO, Not advice and DYOR.
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