The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Robert Justin Marcus - JPMorgan Chase & Co, Research Division - Analyst
: Marcus, JPMorgan. Congrats on the nice data today. I think a lot of people were struggling to put in context, how do we think about what are the
outcomes in tricuspid patients? What is the acceptable mortality, stroke, adverse event rates -- serious adverse event rates? And how would you
frame these in relation to other alternatives? Or are there other alternatives for these patients?
Ted Feldman
Susheel, do you want to address?
Susheel Kodali
Sure. So I mean, I think we're talking about a population that is fairly sick to start, that we don't have treatment options for. These are patients that
are not surgical. And so when you're talking about nonsurgical patients, we looked at -- these patients were randomized to medical therapy, where
we had a performance goal to look at the safety of the device. We had to derive that performance goal and, as expected, things -- from something,
because there was no predicate device. So we used a surgical series of 2,000 patients. And using that surgical analysis, we had a performance goal
of 43.8. If anything, that performance goal is probably underestimating what the mortality would be in the population we actually studied. And
so the event rates -- the safety profile met the performance goal.
The question you're asking, what is acceptable? As a position, not as anything else, lower is better. But the bleeding events were less than we saw
before. They were 10% -- only 5% really were related to the procedure. There were -- and what the efficacy will be, we see elimination of TR. Our
hope and my expectation is that when we get the full data set at 400 patients and we get the 1-year mortality in heart failure, that elimination of
TR will translate to a mortality and heart failure/heart surgery benefit. That's hope, right? But that's what we're studying. And so we just -- we're
not -- we need to wait for the full data set for that.
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