Competitor - JenaValve, page-18

Can anyone clarify if other TAVR makers ‘first in human’ trial related to trialing the complete TAVR valve (complete with catheter use) or involved testing the valve/leaflet portion via SAVR initially?

I’m trying to get a better understanding of the time to market for AHZ’s TAVR from now.

With little basis for my current assumption I’m guessing 5 yrs? 2yrs for SAVR, trial and outcome plus 2yrs for TAVR trial and outcome, 1yr stuffing around with trial design/patient recruitment?

Some figures below for SAVR / TAVR average device costs (and the associated benefits).

TAVR = $30k USD
SAVR = $ 5k USD

Economic Implications of Transcatheter Aortic Valve Replacement in Patients at Intermediate Surgical Risk
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.116.021962

”TAVR may provide both high clinical and economic values in intermediate-risk patients, but final conclusions will require the completion of rigorous analysis. In addition to the aforementioned issues, this analysis may need to consider the issue of long-term valve durability. Most high-risk patients with aortic stenosis are elderly and, thus far, it has appeared unlikely that long-term valve performance would affect cost-effectiveness. Whether this is also true for younger, lower-risk patients is not yet known.”

Emphasis mine in extract above.

I guess AHZ could begin selling SAVR valves within a few years, assuming good trial results, however at $5k I doubt that would cover costs. Perhaps SAVR gets licensed for a better deal than we have see previously?

I can’t see how decent data on AHZs TAVR (potential) to produce superior quality-adjusted life-year gains could be published in less than say 10yrs from now?

I recall some surgeons had used ADAPT material to manually replace heart valve leaflets (a few? years ago) perhaps that data could be used to verify anti-calcification however I would imagine long term superiority would need to be valve against valve.