I think it's likely that the 2024 valve-in-valve revenue Wayne is referring to are procedures the FDA would allow under its Humanitarian Device Exemption. Valve-in-valve may qualify for that as the exemption is for rare diseases affecting fewer than 8,000 patients in the US per year and with VIV accounting for around 5% of the around 75,000 TAVR procedures, it qualifies numerically.
However, I'm skeptical that the FDA will allow it for a life-sustaining device still in clinical trials when there are approved replacement valves currently available to be used for the procedure. Obviously I'd love to see us get the HDE and make huge differences in patients' lives, and generate revenue, but I wouldn't bet on it at this point. Wayne said he hopes to have more info at the annual shareholders' meeting about possible VIV procedures next year so we'll see.
Also, I think if we get an approval in 2026, it would be very late in the year and the odds are that it will happen in 2027. The timeline just doesn't make sense for an earlier approval. I figure that the first procedures for the pivotal trial will start around a year from now, probably a little later. The trial will take at least two years. Then the data will have to be processed and submitted to the FDA (which always takes longer than expected, especially for 1,000 patients) and finally the FDA will have 6 months to make a determination on the approval. So the pivotal trial could be completed in June/July 2026 with another 3-4 months to get the data submitted and 6 months for an approval. That would put the approval in Q2 2027. That seems realistic to me although I wouldn't be surprised if it happens a little earlier or later..
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