I will remind you also that Ardian was a breakthrough device had that designation and in the world of MSET ruling that would have met automatic coverage. We don’t know yet what the TSET pathway is going to look like. We will find out more about that in the fall timeframe, I suppose, or in the spring timeframe. But we do think that the novelty of this therapy, the desire of patients, and of course, the public health benefit that this can provide is going to be compelling to both public and private payers around the world.
Geoff Martha: Thanks Josh. Take the next question please Brad.
Brad Welnick: Yes. We will try Matt again. The next question will come from Matt O’Brien at Piper Sandler. Matt, are you there?
Matt O’Brien: How about now?
Geoff Martha: Yes, we can hear you now.
Matt O’Brien: Thanks for taking my questions. Sorry about that. I guess just to follow-up a little bit on Josh’s question, and I know how enthusiastic you still are about Ardian. But I think the ambulatory number is one that is a little bit more robust in the office-based number. So, why would clinicians and payers be so interested in doing these cases or we are paying for them given the ambulatory feedback that we have seen? And are you guys still thinking about the market is $500 million by €˜26, $3 billion by the end of the decade?
Geoff Martha: Sean, do you want to get into the specifics on the ambulatory versus the office?
Sean Salmon: Yes. Matt, I think if you just recall how that study was done the patients were witnessed taking their blood pressure medicine in the morning. And whether they were taking that for the full six months or not, or they just took it that day, you saw the change in blood pressure that was during the daytime not what we have seen before in these prior trials. But at night time, there was still a reduction in ambulatory. So, I think the simple story here is that patients weren’t taking their medications, except on the game day and their blood pressure drops. Now, we don’t know that for sure, we didn’t test blood in urine every day. We just test it on game day. And we know that there were more medications in the patients that were in the control arm than in the treated arm.
And as Geoff said, the changes increasing medication, decreasing medication, taking even medications for blood pressure that weren’t even prescribed maybe from their medicine cabinet, maybe from their spouse or partners medicine cabinet. There is a lot of changes in medicine, which we know were present different than the prior studies. We actually have that proof now that we can measure the drug metabolites. So, a cleaner, if you will, measure is that morning blood pressure, we took the office blood pressure. And that blood pressure is the one that’s used for all the epidemiology studies that show what the reduction in blood pressure means for the avoidance of events and reduction of cost. And it’s also the primary endpoint that’s gotten just about every €“ I think maybe every pharmaceutical approved for the treatment of high blood pressure.
So, it is the robust standard. In fact ambulatory is not even reimbursed in this country. So, it’s not used routinely in clinical practice. So, it is a robust measurement that was consistently performed throughout this trial and across the other trials that we have done. So, I am confident in that part. In terms of the market size, we are very confident in this therapy. There is 1 billion people with blood pressure problems around the world, even if very small amount gets you to the kind of market growth that we think is going to be meaningful for the company. So, we are very confident in this therapy and that is approval and ultimate uptake.
