Geoff Martha: Alright. Thanks, Que. I mean so I mean, Travis and others, I mean, as you can see, you know, beyond the fact that the areas that we get questions on Type II intensive, hypertension, AFIB, obesity, besides the fact, these are just woefully underpenetrated from a medtech perspective, we’ve done all the analysis that, you know, Laura and Que just gave you the tip of the iceberg of. And that’s why, you know, we’re — we feel strongly that, we don’t see these drugs impacting medtronic’s growth, medium or long-term. So I hope that answers your question and then some.
Travis Steed: Yes. Super thorough answer. Thanks a lot.
Geoff Martha: Thanks, Travis. Next question, please, Brad.
Brad Welnick: We’ll take the next question from Larry Biegelsen at Wells Fargo Securities. Larry, please go ahead.
Larry Biegelsen: Good morning. Thanks for taking the questions. Just two product questions for me. One for Sean on Ardian congratulations. Don, can you talk about the ASP, you know, the reimbursement pathway and the ramp? And for Brett, you know, the slides talked about completing the six month primary endpoint on the pivotal TITAN 2, IT&S trial. Does FDA want 12 month data? Could you talk about the form factor here? And how you see IT&S being positioned relative to sacral neuromodulation? Thank you.
Geoff Martha: Well, Larry, it’s Geoff. Good to hear from you, and thanks for the question. On, before I turn it over to Sean on Ardian, I just — I do want to just say, look congratulate the team, here at in the cardiovascular space of medtronic and leaders passed, I mean, this has been that have been involved. This has been a long journey, and we are really, really, excited about the approval. You know, we have a lot of data here in our RCTs. You know, we consistently saw, a mean 9 millimeters to 10 millimeters of mercury absolute office blood pressure drops at the initial primary endpoints, in this case of three, six months, and actually more in the real world setting and additional drops over time from these primary, assessments.
So, you know, this is a game changer and look this is compelling as the data is and as much as we have. It doesn’t even tell the whole story. I mean, you talk to physicians out there that are involved in our trials, and the excitement’s palpable in patients. Here, we have a number of patients been on this for years, and talking to them and how it’s changed their life. And we’re actually having a patient come in and talk to the entire company here in a couple weeks. It’s very exciting. And so a big opportunity for patients, and a real big opportunity for us too. And so getting into some of the specifics, you asked about reimbursement. I’ll turn that over to Sean, and then we can go to Brett to talk about — I believe you’re asking about the tibial opportunity and but why don’t we start with Sean?
Sean Salmon: Larry, thanks for the question. As you know, the ramp is going to be highly gated by reimbursement, and we’ve been working that in parallel with the regulatory approval all along. We see the payer split to be roughly 50:50 between Medicare and commercial payers of private insurance, and we’ve been, of course, pursuing both local and national, coverage determinations from Medicare. And that’s an important input into the private payer decisions that will happen state-by-state and payer-by-payer. We’ve been in contact with those private payers, the largest ones, certainly. And the response so far has been very open and willing to engage with us to understand our data. And what’s particularly of interest to them is the long-term data, which is atypical for a new therapy like this to have thousands of patients out three years from the therapy.
So that’s encouraging. Of course, you know, the Medicare population is the most important for us and to your question, that there are these alternative pathways that have been established by Medicare for temporary add-on payments, both in the inpatient setting with NTAP or the new technology add-on payment, as well as in that outpatient setting for transitional pass through payments or TPP. And given that the simplicity spiral system is a point through device designation. We will avail ourselves to those pathways for approval, over that two and three year period as we work to establish more permanent, reimbursement for like a national coverage determination. On that front, there is this T-Set pathway or the transitional coverage for emerging therapies that we’re going to avail ourselves to.
It’s not finalized yet. We look forward to, that ruling coming out. We’ve seen the commentary has been largely, very, very positive along the way and in line with what we had been suggesting both to CMS and the Biden administration as well as other stakeholders along the way. And of course, CMS is also considering other refinements to covers with evidence development programs that we’ve used successfully as we’ve established many, many therapies as you know, including TAVR, Micra, ICD, CRT devices over time and we’ll avail ourselves to those as well. So rest assured, we’re working hard on reimbursement. It’s really critical for the ramp of this technology, and we’re getting a degree reception so far.
Geoff Martha: Okay. Thanks, Sean. Brett, you want to answer part two here?
