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 Riskhttps://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.
