AVR is currently my largest individual stock position so I'm very bullish on the future but I don't see valve-in-valve revenue happening before the pivotal trial is completed and the DurAVR is approved by the FDA. The only avenue is a Humanitarian Device Exemption, as Wayne has mentioned in the past (but did not yesterday), and I do not believe the DurAVR can qualify as there are currently approved ViV options even though they may be inferior.
To get an HDE, this criterion must be met :
The device would not be available to a person with the disease or condition in question without the HDE, and no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE),5 is available to treat or diagnose such disease or condition
Both HDE and IDE refer to devices in trials so the criterion can only be met when comparable devices are still in trials, not approved as other TAVR valves are currently. In page 6 of the FDA's guidelines it states that if another device does receive Premarket Approval, an HDE will be withdrawn.
I would love to be wrong and pleasantly surprised but I am very, very skeptical that the FDA would allow a life-sustaining procedure without the 500-1000 patient safety data needed for a full approval when there are approved valves that can do the job. There is a reason the FDA requires a trial with that many patients for an approval. An HDE is for procedures where there are no other options so I do not believe we will see ViV revenue before an approval probably in 2027.
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