Good morning, everyone. Good morning. We're going to get started here. Let's see. We'll get the slide advanced here. There we go. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thanks for coming to our Restorative Therapies Group Investor Briefing here at the North American Neuromodulation Society conference here in Las Vegas. Welcome to those joining us around the world on our webcast. Before we get started, I want to note that we could make some comments that may be considered forward-looking statements, and actual results might differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC. We do not undertake to update any forward-looking statement. I encourage you to go back and read this slide.
The slides we're presenting today, they are available on our website, which is investorrelations.medtronic.com. I want to note that given today is the last day of our fiscal third quarter and we are in our quiet period, we won't make any qualitative or quantitative comments on the quarter, including topics such as sales, market growth, or market share. Today's webcasted event will last about an hour. Brett Wall, our Executive Vice President and President of Medtronic Restorative Therapies Group, will make some introductory remarks. We'll have presentations by Marshall Stanton, who is our Senior Vice President and President of Pain Therapies, and Mike Daly, our Vice President and General Manager of Brain Modulation.
We'll end by having Matt Thomas, who's the VP and GM of Pain Stim, and Charlie Covert, who is the Vice President and General Manager of Drug Delivery, join Brett, Marshall, and Mike to take your questions. We plan to wrap up in about an hour at 9:30 A.M. Pacific Time. With that, I'll now ask Brett to come up and make some introductory remarks. Brett?
Good morning, everybody, and thank you for attending the event. I'll jump in and get started. First, it's an exciting time for Medtronic and Medtronic's pipeline, particularly in RTG. If you look across in RTG, we have exciting things that are happening both today, in the near term, and then in future. If you look across the portfolio, we have a lot of things driving growth now. Our enabling technologies, which is a market-leading spine and cranial enabling technologies for navigation robotics and imaging and powered surgical, which is really leading the way in this revolution in spine that's occurring right in front of our eyes. In particular, that I want to point out there on the enabling technologies is we've done our also first case of our cranial robot. We have a small cranial robot.
We did our first case in Phoenix last week. This is an exciting new technology that's married to our StealthStation. We're moving very aggressively into these fields and into these areas where we can place and wrap it in our Surgical Synergy portfolio, which includes navigation, our imaging, and robotics and powered surgical. The Riptide Aspiration System, this is our React catheter along with the Solitaire X. This is a market-leading system for stroke. We continue to like the stroke market and the prospects. Titan. Titan is an acquisition, that's inorganic, that's driving growth. The thing about Titan is it's not only an interbody that we acquired, a titanium interbody, it's actually a technology because of the nanoLOCK surface modification that is done to this. What's interesting about that is that surface modification does not allow a biofilm to form.
That's a very interesting concept when you start thinking about proliferating this technology into other implants. Future. Marshall will be talking today significantly about DTM therapy on Intellis. We're really excited about what this therapy can do. This market responds to new technology and to data. The InterStim Micro and the SureScan MRI leads. This product has CE mark now in Europe. We've done our first case as of last week. We are in the market and we're excited about where this goes. Full body 3T, 1.5T MRI. Percept Deep Brain Stimulator. Mike Daly is here today. He is the Vice President, General Manager of the Brain Modulation business, and Mike will talk to you about this. We are back. We are in the market. We are in Europe. We are doing cases.
That's a really, really exciting technology for us because it's going to allow us in the future to close the loop and actually have closed loop therapy in the brain. Our NIM monitoring system. This morning, we just received CE mark approval for the Pipeline Vantage with Shield Technology. This is a new aneurysm device within Europe. It is a smaller system allowing to go through a smaller catheter. It has the surface modification that mimics red blood cells and helps in the process when you're using dual antiplatelet therapy. Beyond, we have new hemorrhagic stroke intrasaccular devices. We're continuing to iterate on the spine technologies and then the closed loop deep brain stimulator. A very full pipeline, and we continue to invest in this particular area of RTG because of the markets.
Today, we're going to get a little more in-depth on the technologies here. What you're really witnessing here is a really large investment and the culmination of that investment across our entire neuromodulation portfolio. Marshall, as I stated, will talk about DTM. Mike will be talking about the Percept device, which we are really excited. I won't steal any of Mike's thunder, but we're really excited about this device and what it can do. It actually changes the entire dialogue about what's possible in deep brain stimulation, and it's very, very exciting. Our InterStim devices and the Micro for sacral neuromodulation, this is a 3 cc device, the micro. The smallest device on the market. Best battery Overdrive technology on the market. 3T 1.5 full body MRI. We are going to be more than just competitive in this particular space.
When you look at this and you look across the board, we have an exciting neuromodulation platform that we're talking about here today, and you're going to see a lot of exciting things moving forward. With that, I'll turn it over to Marshall Stanton, our Senior Vice President and President of our Pain Therapies business unit. There you go, Marshall.
Thanks, Brett. This is a very exciting NANS for Medtronic with all the things that you've seen going on. We've announced some things in press releases. If you've been down to the booth area, you've seen many of the new things that we have on display. Of all the things, I have to say for me, the most exciting is the acquisition of Stimgenics and now our ability to put DTM on our Intellis system. The Stimgenics group has been investigating mechanisms of chronic pain and stimulation patterns for 10 years. They started with pre-clinical studies looking at a novel therapy to address a unique mechanism of action of chronic pain. They went from that to human feasibility trials, and then went from that to a randomized controlled clinical trial. Traditionally, when people think of spinal cord stimulation, they think of neurons in the spinal cord.
There are actually cells called glial cells that are much more abundant, more than 10 times the amount of cells are glial cells compared to neurons. What happens with pain is that with acute pain, glial cells get activated, and they aid in the transmission of pain, and that's normal. What can happen is these cells can become dysfunctional, and it's been shown that they play a role in chronic pain. Stimgenics developed an algorithm, DTM. They did basic science research on it that showed reversal of pain behaviors in animal models, and that was significantly greater than pain reversal with either low-frequency or high-frequency spinal cord stimulation. They also showed that DTM modulates the neural-glial interaction in animals, as assessed by gene expression and also by protein release. This was also not seen to that extent in high-frequency and low-frequency stimulation by itself.
The randomized controlled trial was highly significant, both statistically and clinically. The algorithm was developed for Intellis, and the feasibility and randomized controlled clinical trials were run on Intellis. The data is impressive. The primary endpoint was looking at responders to back pain, and it used the typical 50% reduction in the VAS score, and the results showed that those patients who were randomized to DTM therapy had an 80% response rate as compared to 51% in those randomized to conventional spinal cord stimulation. That was highly significant statistically and obviously clinically as well. Some people have looked at very high responders. Some people have called that profound response. Some have used the term super responders. It's typically been called those who respond with over an 80% reduction in their pain score.
When the analysis was done, patients who were randomized to DTM, 63% of them were these profound responders. That is, their pain reduced 80% or more. That compared with 26% profound responders with conventional spinal cord stimulation. If you look at the reduction in the VAS score, the DTM group started with a mean of 7.26 and had a reduction to 1.88, a 74% reduction, compared to a 46% reduction in the conventional limb. As I said, DTM therapy uses a precise proprietary algorithm that was designed and proven only on the Intellis platform in this randomized controlled clinical trial. What do you get when you use the Intellis system? Well, first off, now you get DTM therapy, which I've talked about. You also get the simplicity and versatility that we've been known for.
We have been talking about versatility being needed in spinal cord stimulation for more than three years. It's an acknowledgment of how correct we are by seeing other companies now using that exact same phrase of versatility. We know that there isn't necessarily one algorithm that's going to be right forever for everyone. So it's important to have that versatility that Intellis has. In fact, if you remember, we've been running a trial called the VECTORS trial, which we've presented early data on previously. At this meeting, 12-month data has been presented, and it shows that the pain relief that's seen and the responder rate that occurred at three months has persisted to 12 months. With Intellis, you get what I would argue is the best battery technology.
I'll remind you that we are the only company that for spinal cord neurostimulators designs, develops, and manufactures our own battery. Our battery is different than everyone else's. We use proprietary battery technology. That's why we're able to develop the smallest battery, a battery that can charge from zero to full in 60 minutes, and a battery that at nine years has 5% battery fade. We are so confident in our battery technology that at this meeting, we're announcing that we now will warranty our battery in Intellis for nine years. That's not a prorated. You get full payout if the battery does not last nine years. That is by far industry-leading. I challenge other companies to stand behind their product like we stand behind ours. Our SureScan MRI technology in Intellis, the Intellis patients have the most access to full-body MRI of any company.
Additionally, we're announcing a new feature in Intellis, electrode redistribution, that allows for delivery of personalized programming and an algorithm that we developed allows scanning for a patient with over 300 different options being tested in less than three minutes. It's fantastic to be at Medtronic where we can offer a variety of therapies for pain relief that no one else offers. No one else offers a spinal cord stimulator and an implantable drug pump to treat the problem of chronic pain. We're also announcing something new at this meeting, and that's the full launch of our Efficio software. Efficio is a cloud-based clinic patient management system that will make managing pump patients easier, and specifically SynchroMed II patients. One of the things that motivates us at Medtronic is being able to play a role in combating the opioid crisis.
One of the ways that we're playing a role is with our implantable drug therapy. It has been shown that almost half of patients that are started on implantable drug pump therapy for treatment of chronic back or leg pain are off of oral opioids at one year. We developed the Control Workflow to aid physicians in getting their patients off of oral opioids and onto low-dose intrathecal morphine with the ability to potentially avoid systemic side effects. Not only is it obviously beneficial for a patient not to be taking oral opioids, but there's a financial benefit as well. In this published study, there's over an $11,000 saving per patient in implantable drug pump patients who are able to come off of their oral opioids. We are pushing that and investigating in a formal fashion, the outcomes of that with our Embrace TDD clinical trial.
That trial is almost half enrolled. Some interim data are being presented during this conference. We're very excited about where we're at and the future of pain therapy at Medtronic. With that, I'm going to turn things over to Mike Daly, General Manager of the Brain Modulation business.
Thanks, Marshall. Good morning, everybody. I'm Mike Daly. I'm the Vice President and General Manager of Brain Modulation. Thank you for being here. Everybody's talked about things being exciting so far, and I won't be the only one that doesn't. We're really excited in our business right now. The Percept PC, we believe is the beginning of a long-term change in the way that therapy will be delivered in DBS, in the space. It's really transformational. We have CE Mark. We were approved on January 2nd. First implant was last week on the 14th. We're up and running in Europe, and we anticipate being up and running in the spring in the U.S. Percept. I'll talk a little bit about the simulator. I'm going to hit BrainSense first, but I'm going to go back to it in the next slide because that's really the game changer here.
BrainSense technology, it's the first and only commercial sensing that's ever been available in DBS, and I'll talk more about that in a bit. What I don't want to forget about is these other three columns here. We've led the way with MR conditional labeling in DBS. We've always been ahead. We'll continue to be ahead. We're the only device now with 3T. It's the future, and we've got it in this device. The capability is there and on. Our battery technology, Marshall and Brett both mentioned that we have a real advantage there across the board on battery technology. This battery has given us the opportunity in a INS that is 20% smaller, 20% thinner, to achieve 15% better battery life with the Percept. We're pretty excited about that.
I know battery life doesn't always seem to be the most exciting thing, but that changes how many surgeries a patient has to get. That changes their outcome significantly. We also launched new programmers, the clinician and patient programmers, which are tied into this whole new platform, Percept, and the new leads that will be coming later on. We go back to BrainSense. What makes sensing important? We're out right now with open-loop sensing in Europe, and that's what we'll be launching initially in the U.S. as well. With open-loop sensing, when we say you're going to be able to capture these brain signals, you'll hear a lot more about local field potentials, LFPs. Those are the brain signals.
The big thing here that's different is right now, and I don't know everyone's experience level with DBS, but right now we have a constant on, and we'll continue to have a constant on of stimulation. What happens is when they initially program a patient, they spend a few months with follow-ups coming in and looking over patient diaries and feedbacks on how they've been and trying to use that information, which aren't real data, to determine how they're going to program. It does work with very high efficacy, but what we're making a bet on is real data is going to make a difference. Now these clinicians will be able to see what's happened for the patients over the time in between, use that data to inform their programming decision.
We believe in the long run, that's going to give better outcomes, less side effects for these patients moving forward. That's the open-loop technology. We'll be starting a trial in the spring to prove the concept on closed-loop technology. That'll be a couple of years further out. That's when we'll change the therapy completely. Right now it's open loop, and what that'll do is inform programming with personal data-driven numbers that have never been available previously. It's kind of hard to believe that we've been out this long, and they've been doing this kind of like an art, not a science a little bit. I don't want to discount what neurologists do. It's amazing. To think that they've been doing it on feedback from a patient population that has a progressive disease generally, is generally older, generally not in 100% state.
You can see the difference it will be getting real data that you're able to use to inform those decisions. That's all I've got. Thank you for your time. We'll start with the panel. Ryan?
Okay. Yeah, we'll start with Q&A. David.
David Lewis, Morgan Stanley. Just a couple of questions first on Stimgenics, maybe the market. Maybe just a couple of questions on Stimgenics. Can we talk about the IP dynamics around Stimgenics? How proprietary you think the DTM algorithm is relative to peers, maybe battery dynamics, and then just launch dynamics. Should we assume this has got a full commercial launch kind of one week after NANS?
Yep. I'll take the first couple and then let Matt talk about the launch. As I described, the DTM algorithm was designed for Intellis. It's not just how Intellis is programmed, it's how the stim engine in Intellis interprets the algorithm and delivers the therapy. That's what was used in the randomized clinical trial. That's what resulted in the fantastic outcomes that you've seen. Additionally, as part of the acquisition, we acquired intellectual property, and including a patent portfolio. We intend to defend our intellectual property in a strong way.
Commercial launch. Just launch timing.
Yeah, commercial launch. We're starting to roll out now. Obviously, we're sharing the three-month data here at the meeting. We'll start training reps within a week. We're being very deliberate in the rollout cadence. There's, to Marshall's point, a subtlety to the programming, and it's not a just kind of do it any way you want to. It's not generic. It's very specific. The results were generated by a very specific algorithm that's required to be followed. The training is obviously rigorous for our reps to make sure that's followed, and you can expect the results than you've seen in the RCT. We'll finish training the entire U.S. sales force within the next couple of months and be fully launched here quickly.
Yeah. The simple answer is we're launching now. There's a lot to do there, but obviously it's ready to go. It's within the parameters of the approval that we have to run this particular algorithm. As Matt said, we're training our individuals there. It's a fairly straightforward programming concept. We're launching now, and we're not prohibited in any way.
One of the things that we talked about when we first launched Intellis is that it's future ready. You see a few examples of that here. The fact that we can launch DTM right now, the fact that we're launching electrode redistribution, and those are backward compatible with people that have Intellis now.
Okay. A quick follow-up is, do you think you can prevent competitors from doing glial cell stimulation? Just market growth, Marshall, we can talk about that's been the big issue of last year, how you're seeing market growth in the next 12 months, and in light of Stimgenics, how you think your relative share within that market will fare? Thank you.
Right. I'm not going to litigate our patent portfolio here. That's all I'm going to say about that. The market, I'll talk about going forward. We're in our quiet period, as Ryan pointed out. I'm not going to talk about the dynamics of what's going on right now. There are substantial tailwinds for this market. Chronic pain is still an enormously under-penetrated problem in the U.S. and around the world. There's the opioid crisis. This market has been driven by innovation and clinical evidence. We've got innovation. You've seen a lot of innovation from us here today. You've seen a lot of clinical evidence today. We see that as being positive for the market going forward.
Share? Do you think your definitive share taker in SCS this year is Stimgenics?
We feel very good about Stimgenics from a competitive standpoint. Yes, we believe it will take share. Larry.
Thank you. Larry Biegelsen from Wells Fargo. Just a couple on StimGenics and one on DBS. StimGenics, just a little bit more color on the differentiation besides the mechanism of action. Is it paresthesia-free or not, and when are we going to see the full data? I wasn't sure if leg pain was significant or not, and I had a follow-up on DBS.
Yeah. First off, as I referenced there, versatility is really important. It is important, we believe, whether it's with DTM or the Evolve workflow, that paresthesia mapping be done. Programming then is done to comfort, because what you're aiming for is pain relief.
The differentiation, it's a different mechanism, but when you look at other novel waveforms like HF10, what are some of the benefits of this over that? We've heard of a lower charge burden. Is there anything you would point out in terms of how it's differentiated from other waveforms, and when are we going to see the full data set?
Yeah. For most of the patients, the way it's programmed, there shouldn't be any difference in current drain compared to using our Evolve workflow. I'd say that our battery, as I pointed out, is industry-leading and is very user-friendly for patients. The clinical trial is still ongoing. We're going to follow these patients out to a year. The Stimgenics investigators are fully analyzing the data set that they have now, and they are writing that up. They've presented predominantly the data that I've shown here at this meeting. It's going to be a few months of preparation and then manuscript acceptance process.
Got it.
The other thing too, Larry, just on the battery, because it's kind of an interesting question. If you look at the Overdrive and just the battery technology, one thing that's probably not appreciated as much is, and Marshall mentioned, it was the recharge time, right? It's from a flat battery to fully charged in 60 minutes. That's really important. The other thing is fade. We've talked about that a little bit, but over the period of time and over years, when you recharge something, we've all had this experience before. I think Apple does it as planned app obsolescence for all of our phones. Where the fade can drop down substantially, and we're at, what, 5% probably fade over nine years. That battery will react virtually the same way it did at implant nine years down the track.
From a patient convenience, from a patient satisfaction, we believe the battery technology is pretty important.
That's why we're putting our money where our mouth is and going to a nine-year warranty.
Got it. Fair. On DBS, your DBS business has been down slightly. My question is.
We've been a share donator. What are you talking about?
DBS.
Yeah.
My question is Percept PC enough to get positive growth in DBS? I didn't see anything on the steerable lead. Kind of just, is Percept PC enough?
Mike, you want to.
Yeah. Well, first, we're not doing a good job with the name because it's Percept, not Precise. I just want to be clear on that. Percept PC, yes, we do believe we'll get market share gains there. We think we'll stop the bleeding and get growth from this device. As far as the directional lead, we're probably 12 months out on a directional lead. The reason that we're 12 months out is we made a conscious decision that we weren't going to come out with a me-too product. We believe in sensing. We believe it's the future of the therapy. When we were coming out with a directional lead, we were tasked with coming up with a directional lead that was optimized for sensing, to insulate all those wires so that you could get the best possible noise.
That's a hard project, and it's taken a little bit longer because we're going after a premium product.
You guys are 12 months out?
Yeah.
Okay.
Matt?
A couple of follow-ups, one on the electrode redistribution. If maybe you could just talk about the competitive advantage there, how you expect that to affect the business or your relationship with clinicians, and then a follow-up on the deep brain stimulation side?
There's a segment of the physician population that has told us that they like the idea of being able to put different amounts of current onto different electrodes. We were responding to a segment of the customers, and that's why we implemented it. Matt, anything else you want to add?
It's a feature set that some physicians like, but not necessarily tied to an outcome so much as just control.
Okay.
We're now providing-
Just to be clear on DTM, there's nothing special or different about where you put the electrode positioning or anything like that. These are flexible.
We're not going to comment on that, but we use the full array of target and energy profile to deliver DTM.
Got it. Thank you.
Yeah.
On deep brain, maybe if you could talk a little bit about sort of the advantage of open loop in advance of having a closed loop system and what you think that potentially can do if you're studying the impact of that, just what we can expect maybe over the next 12, 18 months as you get to directional and then closed loop?
Sure. Well, closed loop is the goal. That's what we're going to get. Open loop right now is kind of a lily pad to get there. A lot of the doctors aren't that familiar with sensing. This is an opportunity for them to start getting their feet wet with sensing. The device, Percept, we had an investigational device prior called PC+S. The Percept device has all the investigational features of PC+S. Now Marshall mentioned earlier about devices that are upgradable. Is Percept. That will be the same device that becomes the device that we use for the closed loop when we get there. To go back to the open loop question, though, it's really.
It's really kind of an amorphous thing right now because people haven't had it. They haven't had that data.
Well, one add that I'd say, Matt, is patients today keep a diary.
Yeah.
It's probably inaccurate because it's uncertain of what the data really is. What the open loop does is record all this information.
Yeah
in the beta and the gamma bands. What's really important about that is the patients on levodopa, or they have other types of things, you're trying to titrate them into this band, and the physicians call it local field potentials. They're sensing all this here, and they're trying to keep them in those bands. When they get out of those bands, you get things like rigidity or dyskinesias or other types of things that cause significant problems. The idea here is how do we titrate them and how do we understand when the drug's working or when you need stimulation or both, or one or the other? That is the really game-changing aspect of this particular therapy, is we're going to understand it. We can hear it. Now we're going to run algorithms in the trial on the closed loop to create a thermostat.
DBS is great. It's like we had discovered fire a long time ago. We were cold, wanted to maybe heat up our food. Fire was a really good thing. Fire couldn't moderate the temperature. It could do one thing. That's a bit where DBS is today. We get a great result, but we can't really moderate it. The goal here is for us to create a thermostat, for us to be able to understand this, dial back or increase the level of stimulation to keep patients in the right range for longer periods of time, and do that consistently. To tell you how hard this is and why I'm so proud of this device, Mike's team, the engineers, if we're on the tarmac here at Las Vegas Airport and, I don't know, you guys from the banks probably fly privately all the time.
You're spinning up your Gulfstream G650. We're 100 meters apart, and I whisper while the engines are going fully spun up. You can hear me. That is the noise separation. We're canceling out all the noise of the stimulation because it's a very noisy environment there, and you're pulling out that signal so you can understand what's going on. Open loop's going to give us that information. It's going to allow us then to do the trial. We're going to run the algorithms and close the loop. We're very skeptical you can do this with a wearable device. I think you guys were all at another session here earlier today. We think that going into the brain, sensing at that level, understanding what's happening right there, and returning that back into this system, which can actually do something about it, is the future.
As Mike said, we're a year out of the directional leads. The directional leads will work with that. Directionality in and of itself, it's a good thing to have. We need to have it. We want to have it. That alone doesn't really get the results that this, we believe, is going to get. This is an exciting game-changing therapy.
Yeah. For open loop, the easiest way to think about it is they program now with feedback from a patient, and now they're going to program with data. That just has to be better.
Yeah.
Kaila.
Hey, guys. This is Kaila Krum, SunTrust. Two quick questions. First, I guess, how do you guys think about the virgin back opportunity with SCS? Specifically, I'm kind of curious how you're thinking about, as a company investing in both the spine implant business and then also SCS, how you balance that strategy.
I'll do the first one. Clearly, there's a large population of patients for whom stimulation versus a fusion is an ideal opportunity. There are a number of studies, both RCTs and feasibility in play there that other companies have invested in. We take that seriously, and I think we'll talk more about that in the near term. I won't comment any more other than it's a meaningful population that deserves that care that spinal cord stimulation can deliver. I think relative to spine, my only comment would be we want the right procedure with the right data for the right outcomes at the right time. I think we'll let the data speak for itself to say what patient should get what at what phase.
I think at least from the Stim side, the investments there to do the right thing for those patients will be what we do going forward.
Okay. That makes sense. On Stimgenics, I mean, you guys now have the three-month data, but you've also talked about the importance of showing durability and the nine-year warranty. Just kind of curious, how important is that 12-month data going forward?
I think with any therapy, not just spinal cord stimulation, it's important to track the efficacy, side effects, et cetera, over time, and we're committed to doing that, as I said. About a year from now, we'll be seeing the one-year data.
Chris.
Thanks. Chris Pasquale, Guggenheim. Just want to clarify on DTM. Do you view this as another menu option, or do you expect this to be the default option for Intellis patients that most patients are going to be programmed to going forward?
We have superiority in back dominant pain, so we would say this is where you start with stimulation. Therefore, we've got a great RCT. We'll have the long-term data as well that demonstrates it. We do know that patients get habituated to programming, and therefore having alternatives that are also fact-based, evidence-based is critical. I think as you look across our programming portfolio, instead of just saying, "Well, we can do it," we've built evidence now for DTM. We've got long-term evidence about Evolve and using high dose T9 T10. It's demonstrating how to do what, and ultimately, providing the best fact-based alternatives for physicians to program. We're starting with DTM as the starting point for FBSS patients.
Great. I was just curious if there was any update on the cranial mounted system. That received a fair amount of attention for a program that was still early at the last analyst meeting. Any updates there?
No. We're in early development of that project. That's several years out, before we'd see anything on the cranial.
David?
Thanks. Just wondering if you had an update on some clinical trials. I think last year you talked about a clinical study for PDN. I don't think you've updated us yet on NSRBP. Just where are we on the PDN study? Obviously just for de novo virgin back pain, what are your thoughts on initiating a clinical trial in that area? Thank you.
Yeah, Matt?
Yeah. Again, PDN, painful diabetic neuropathy, is a critical market, a tremendous patient population with a high unmet need. We're clearly evaluating that. We've had many physicians bring forward concepts. As you look at the literature, there are a number of small studies underway as well. We'll talk more about what our plans are there and how we expect to succeed in not just the pain, but how do you get patients from the endocrinologist to the pain physician to get treated, because that's not a typical referral pathway. As we address that population, we'll certainly address how those referrals would take place and the evidence required to do it.
Larry? Go on.
Could you talk about where you are with your SCS closed-loop system? You disclosed that, Geoff disclosed that on a couple calls, kind of threw it out there that you guys are pursuing that internally. Is there any update? How far away is that from market? Thanks.
There's a number of different technologies that we're working on. You're alluding to one there. We've seen great progress in some of them. At this point in time, we're not going to disclose anything more. I think within the next year you'll hear us talking more about that.
Hi. Ben Weaver with Barclays. Just want to ask how the launch of the Accurian system is progressing, and then what are your overall views on the RF ablation market opportunity there are?
The Accurian launch has gone very well. It's beating our deal model. We're excited about the value that it brings to physicians. Clearly the market for ablation continues to grow well, a number of innovations and studies that people are bringing to the market. I think we see that market continuing to be strong over the short term and long term. We're thrilled about Accurian. Obviously ablation's a key part of our customer's portfolio, right? For every spinal cord stimulator, they'll do 10 - 15 ablations. Therefore it's a part of what they do and we have a tremendous opportunity to impact patients in that way. We've got what we feel like is an absolute best-in-class system for both thermal ablation as well as cooled, creating that option to add cooled as reimbursement changes.
Go on. Jason.
Thank you. Jason Mills, Canaccord Genuity. Brett, since you're here, I wondered if you would indulge maybe a question within your purview, but outside of pain, specifically in stroke.
Yeah.
Perhaps talk about what we've seen in acute ischemic stroke market growth over the last year, and whether or not you expect any change in slope for that growth over the next couple of years, and if so, what might drive that one way or the other. Also would be interested in your thoughts on a market I'm sure you've thought about, but potential commercialization for Medtronic in neurorehabilitation technologies. We've obviously heard a lot about virtual reality. There's plenty of clinical literature on it. A big market seemingly. Would love your thoughts on both of those if possible.
Yeah, sure. On the stroke side, we continue to be encouraged by the stroke market. I mean, around the world, it's one of the biggest problems that systems and governments face when they're looking at their population. As we interact with government leaders from around the world, it's one of the first things in their healthcare questions that come up about how can we get help on the stroke market. The RESILIENT trial, which we supported, which was in Brazil, this looked at really the same types of patients that were treated in the U.S. and Europe in the five major New England Journal trials. It was in the public healthcare system in Brazil.
What they were able to do in this randomized trial was get the same results in the public health system, which can be very challenging in Brazil, that you've seen in the United States or in Europe. The value of this therapy is extraordinarily high, and so that has generated great interest in China, great interest in really countries, Romania, many places around the world. We see an ongoing tailwind in stroke. The numbers, Ryan, I don't know if you want me to talk about the numbers right now on the market.
Not the current, but.
Yeah
go forward.
I mean, go forward, we're still kind of clocking it around 20% or in that range. We think there's room to go here, quite a bit of room to go here yet. On the rehabilitation side, it's a big market for sure. It's a big patient market, and not a lot of good options there. What we are looking at is, if we were to enter that market, how would we do it? We think there's some challenges on the coverage and reimbursement. It's a lot of skilled nursing in the coverage and reimbursement area there. We're working to understand it even better, but we see it to be a little challenging there on how that gets paid for over time, for a long time, and the results you get. Now, that being said, I think there's potentially other technologies or other places you could go.
Right now, for post-stroke spasticity in our Targeted Drug Delivery business with Charlie, we have pretty interesting opportunities there where you might want to talk about that, Charlie, just a little bit.
We maintain a therapy, intrathecal baclofen therapy, for patients that suffer from these types of conditions, post-stroke spasticity. That's been a primary focus for us for a couple of decades now. Some very new interesting data just in the last couple of years that showed superiority for that particular indication versus oral baclofen. That's an implantable therapy that we'll continue to drive, but it might be something that we continue to evaluate in a complementary way with some of the things you're talking about as well.
Yeah.
Matt.
Maybe just, Matthew McSweeney, Credit Suisse. Just one follow-up on the market generally, and then a question that a lot of us are trying to get to, which is just the stabilizing market growth rate. Some of your competitors, I think most folks haven't been committal to sort of a normalized rate where SCS in particular will kind of settle. Given, Brett, your sort of visibility across RTG and spine and the importance of FBSS to this indication, just wondering if that's something that you're seeing in terms of either tightening of payer restrictions five, 10 years ago or improving outcomes, which obviously spine has been focused on.
Yeah.
That or any other trends you're seeing that might be able to explain some of the trends we've seen in this end market.
Yeah, I think, if I take a step back and I look at spine, we've been kind of encouraged at spine to see the forward growth there be maybe 5% procedurally, 2.5% price headwinds, so maybe net out in that 2%-3% range. With robotics and with the other technologies we have, now with the acquisition of Titan, we kind of like the traction we're getting with those types of things and the investments we've made there, and we're continuing to do that. We like that. On SCS in particular, one of the reasons I kind of applaud the team because it's kind of nice when you take a new job and you have something new, like two months afterwards. You get a lot of credit for that you probably shouldn't get.
It's a good thing because we see the market generally respond to the technology and respond to a new type of stimulation parameter that actually has data, and the data actually is pretty compelling. Now, we need to see what it's going to be over 12 months, and we see what's been there. We think that's going to be a tailwind for us as we go forward. We think it's going to be a tailwind for us. The market's been a tough market, and we're encouraged by what we see with this technology and what we think it's going to do for our team and as we move forward. That kind of M&A for us is pretty efficient, so expect more of it.
Marshall, did you want to add anything on the SCS market slowdown, thoughts on that?
Yeah. Thank you. We've done some market research. First off, coverage has not changed for spinal cord stimulation. One of the things that comes out in our research is many physician practices are seeing an increased burden in the authorization process. That probably came about because payers are increasing applying the rules that they had, more so than they did before because they were seeing very rapid growth in this area. We've reacted to that. We've done a number of things. One is we've done educational webinars to make sure that physicians and their practices know what's the most efficient way to submit, what do you have to make sure that you have, things like that. We've done some other things also that I won't comment on here. We think that's going to help with restoring growth as well.
Yeah. Thanks.
Ryan, if I could.
Sure.
--one on Mike Larry. Mike, in DBS, there seems to be a lot of excitement in the clinical community for closed-loop system for epilepsy. I didn't hear you talk about that today. What's the pathway forward there?
Yeah. Well, the epilepsy DBS market, it's a market development opportunity right now. It's a growing market, but it's very small base, and that clinician population is very conservative. There's a lot of trying and waiting, trying and waiting, and that's just on DBS as it is now. We're trying to develop the DBS market in epilepsy. We're focusing on the closed loop. The focus of that is really movement disorders. We will get there on epilepsy, but the focus is on the movement disorders.
I think the other thing too, Larry, is as we look at it, we're kind of playing in a lot of these epilepsy markets in a way and kind of around it. DBS is there. We have an ongoing clinical study on Visualase for a specific type of epilepsy. Now with our new what we call a Stealth Autoguide, which is our kind of small cranial robot, that can be used to place the SEEG leads and do it in about four minutes a piece, so it's more efficient. We're interested in the space, and as we kind of surround it with these other technologies, I think we're just interested in epilepsy in general and making some investments there.
Yeah. Any other questions? Okay. Thank you very much for attending. I appreciate you being here today. Let me know if you have any follow-ups. Thank you, everyone.