Awesome post.
I'm definitely leaning to the idea that we will get early approval for valve in valve procedures for exactly the reasons you mentioned but also ONE more important one....
Mr Paterson commented at the AGM in regards to exactly this issue that we have some of the best interventional cardiologists advocating on our behalf to the FDA to get our product approved (early access for VIV....) whilst I don't have a lot of faith in the FDA as an organisation I do believe in this instance they will heed the advice of these world leading experts and do the right thing.
Anyway, time will tell!
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Ann: Exceptional Results in Second Valve-in-Valve Case, page-31
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