And then as we gather more and more data, work with CVIT to show that the product can be safely used in smaller centers and centers without surgical backup. And as you’ll recall, we have that kind of stamp of approval in the US from Sky already. So, there is there’s basically a certain number of centers that we have agreed with CVIT that we cannot access until we generate more data and we’re generating those data now. So, with the centers that we really can access, which account probably 75% of the PCI in Japan, we’re over 50% launched — or we’ve launched over 50% of those centers, and we’ll launch the remaining ones in 2024.
Imron Zafar: Okay. And what about the peripheral IVL side in Japan, what’s the latest timeline there?
Isaac Zacharias: We haven’t disclosed the time line yet. We’re working right now with the PMDA to establish the regulatory path. And then once that’s done kind of first half of this year, we hope to have the path established, then we’ll start lining out the timing and the, or the steps and the timing to get there. And at some point, we’ll tell you what that is.
Imron Zafar: Okay. And then one more international question on India. Obviously, a massive PCI market. Can you just remind us where you are there at this stage and how you’re thinking about that opportunity over the next few years?
Isaac Zacharias: Sure. We have a distributor in India. We established the distributor in 2020. We launched — coincident with coronavirus in February 2020. So the — as that country has kind of gone through some ups and downs like the rest of the world, we’ve gotten a good footprint in India through a distributor. We’ve generated really nice post-market data in India, post-market registry over 1,000 patients, all comers, core lab adjudicated. Those were presented at, those data were presented at TCT last fall. And we continue to have really nice momentum, particularly on coronary in India.
Imron Zafar: Okay. And then just one very quick pipeline question. Have you guys started human cases with the Aortic Lithotripsy product yet?
Doug Godshall: We have not. No.
Imron Zafar: Any estimated timeline?
Doug Godshall: This year.
Imron Zafar: This year, okay. Perfect. Thank you very much.
Operator: Our next question comes from the line of Danielle Antalffy. Please proceed with your question.
Danielle Antalffy: Yes, hey good afternoon guys. Thanks so much for taking the question. Congrats on a strong end to the year. Doug, I was going to ask about C2+. And how are you seeing that being adopted? I know it’s early days. You said feedback has been good. But are you seeing it motivate more physicians to pick up IVL and do vessel prep in their patients? Or is it right now more about existing users treating more patients and accessing those tougher to treat patients?
Doug Godshall: Yes, I’d say it’s more adoption existing users versus new users. And that’s, and the more adoption is going to be the with all of the different tailwinds we have, reimbursement and technology tailwinds followed by another technology upgrade next year. It’s really finding ways to help people who use shift from 4% to 10% and from 10% to 20%, helping give them a good reason to use ShockWave more than they already do. Those who don’t use the device are yet are in the minority and less of a sort of much less opportunity for us to drive growth with because they’re probably also pretty low volume operators.
Danielle Antalffy: Okay. And that was kind of my — one of my follow-up questions. You already touched on it in existing users to both to IVL and [Technical Difficulty] large number of patients [Technical Difficulty]
Doug Godshall: So, your phone made it tricky to interpret your question, but I’m going to, I’ll restate your question as best I can, and you tell me if I’m wrong? So, what is the impediment to increase use of IVL or physicians?
Danielle Antalffy: Sorry about that.
Doug Godshall: No, that’s okay. It’s, it just makes it a little more challenging. So, the biggest reason historically has been A, is the economic concern. We have a premium device that we priced at a level that we thought both reflected the value and would ultimately lead to a strong reimbursement position that would be beneficial to the hospital. Thankfully, the work Rob and team did was successful. We were successful in securing our own DRGs, which we’re shocking on the coronary side. CPT code, and we think ultimately will also yield sort of landing in the highest APC level for coronaries. So, but the initial reaction to the price was so this is a high-priced device, and there was a lot of anxiety with CPT that’s a little unusual in terms of a reimbursement mechanism, and so there’s always been a perception amongst physicians that were not really reimbursed even though we have been.
So, there’s a there’s always been a reluctance in many physicians’ hands and minds to, like I’ll only use ShockWave when I absolutely have to because it’s an expensive device. So, now that the first two of the three building blocks for eliminating that economic anxiety with DRGs and CPT code are in place. We think this year will be the first year where a lot of that economic anxiety is ameliorated. The second — another reason why they have been reluctant historically is I’ve got this long diffuse lesion. You’re going to, I’m going to have to pull two catheters to treat it. Maybe I’ll just use atherectomy instead of ShockWave. C2+ addresses that — lung diffuse reluctance. It also helps diffuse the sort of perception, misperception that ShockWave is less effective on centric or nodular or calcium.
So, now we give you more power, you can treat those eccentric lesions with one catheter. So those are really the two of the big headwinds we had faced the biggest being the economics. And then ultimately, the, I think the last one of the sort of next hurdles that will knock down is the our device is very deliverable, but it’s not as deliverable as physicians would like. So, there are times when they choose not to pull it because it’s bulkier than a regular angioplasty balloon. So, I’ll just use something else. That’s a 2025 fix that we’ll have with Arrow. So, we’ve got, each year, we’ll be knocking down the remaining, some of the remaining pressure points that have capped utilization, and we think we’ll just keep uncapping utilization each year.
Danielle Antalffy: Thank you so much.
Operator: There are no further questions in the queue. I’d like to hand it back to Doug Godshall for closing remarks.
Doug Godshall: Thanks so much, and thanks, everybody, for your time and attention. Looking forward to another great year in 2024 and delighted to have Renee on board. Look forward to chatting with you all as the year progresses.
Operator: Ladies and gentlemen, this does conclude today’s teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.
