A special access program is definitely possible in Australia as we had one for CardioCel. Especially as we have Dr Poon advocating for us.
Who knows with the FDA but they will be given the Canadian results as they harmonize with the US on matters of unmet medical need.
We will definitely be angling for early access use in the states.
The best way to think about DurAVR in VIV is to almost consider it like a second device with its own $3 billion stand alone market.
The cherry on top could be a potentially quicker pathway to market than our primary market in first time aortic stenosis valve replacement. Not to mention the potential for Breakthrough Device Status and the privileges that brings.
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