Eire has postulated that the trial has been delayed due to valve-in-valve procedures being inserted into the EFS, presumably in hopes of getting a Humanitarian Device Exemption, which would allow up to 8,000 DurAVRs per year to be sold for ViV long before FDA approval. That lines up with what Wayne has intimated in the past and with what Wizza has heard so maybe that's what's happening behind the scenes.
It would be a bit of a gamble because we all know the FDA tends to move at a glacial pace and delays lengthen the eventual time to approval. It would be very much worth it if we get the HDE but I'm still skeptical that we can under the FDA's guidelines.
Eire has postulated that the trial has been delayed due to...
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