Matt Henriksen
👤 SpeakerAppearances Over Time
Podcast Appearances
And, you know,
You have gone with the peripheral first and just your thoughts on why going there first was better than the coronary and just kind of how that helps with the commercial launch.
Okay.
So tell me more about that coronary trial.
And, you know, the interesting thing, too, is the PMA approach this time for coronary because, you know, you did peripheral 510K approach and you still have good, you know, clinical data, robust clinical data supporting, you know, the pulsile technology.
But you use the predicate of shockwave peripheral technology.
Right.
coronary, there is the predicate shockwave technology, but you're still doing the PMA.
Was there a reason for doing the PMA for coronary then?
Yeah, but you're good at listening to instructions.
All right.
And then, you know, the other thing, too, just with the pipeline and, you know, the other thing with peripheral IVL in general is there's the above the knee section and the below the knee section of IVL.
Yeah.
We haven't talked it through, but I'm assuming the Power PAD2 trial, that was all above the knee, correct?
And then I'm assuming there's also work to be done similar to what you're doing with coronary for the below the knee segment?
It seems like the fact that you're able to compress your balloon because you don't have those electrodes out front allows you to even cross even narrower lesions below the knee.
And so, you know, we have a lot of different developments going on.
You're building up your inventory for the above the knee indication when that gets approved.
You get your clinical data for the coronary, clinical data for the below the knee.
How are you managing the allocation of capital for these kind of, you know, for a small company, large capital or large projects?