Okay, I'm showing 1:15 P.M. Central Time, so we'll go ahead and get started. Good afternoon, good evening, and good morning, depending on where you're joining us today. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thanks for joining us for our virtual briefing to discuss our neuromodulation business and the data that's being released in connection with the North American Neuromodulation Society virtual meeting. While we're not together today in Orlando as we were originally planning, I do hope everyone is staying safe during the pandemic and look forward to seeing you all in person again hopefully. The webcast will last about an hour. We'll start with a brief overview of our Neuroscience Portfolio given by Brett Wall, and then following that, other members of our neuromodulation management team will present. After the presentation, we'll host a Q&A session where we'll take questions from the sell side who have joined the Zoom platform. The slides that we're presenting today will be available on our website, investorrelations.medtronic.com at the conclusion of today's presentation. I also want to note that today's event is being recorded and will be available for replay on our website. For the Q&A session, I want to reiterate for the sell side analysts what was on their invitation. If you intend to ask a question this afternoon, please make sure you're connected to the Zoom platform via the link in the invitation you received from McCartney. If the sell side would like to ask a question during the Q&A session, please click the raise hand button in the participants panel next to your name. Next slide, please. 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 given risks and uncertainties. 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, and we do not undertake to update any forward-looking statement. I encourage you to go back and read the slide. Next slide. Okay. With that, I'll now turn the event over to Brett Wall, Medtronic Executive Vice President and President of our Neuroscience Portfolio. Brett? Ryan, thank you very much. For those who have joined the call, thank you for spending this hour with us today. Although, as Ryan said, we would have really appreciated doing this in person, we appreciate everyone's flexibility of coming online. Just a quick overview of our neurosciences portfolio. If we could move to the next slide, Joe, I want to just give a quick overview of the five operating units that we have. Neuromodulation, which we will talk about in detail today, led by Dave Anderson. The cranial spinal technologies, we have a number of capabilities that we are expanding with Mazor, with new and innovative spinal implants, then, of course, the Medicrea transaction that we finalized last year, which includes AI surgical planning and personalized, customized implants per patient. Neurovascular coming up. We have a number of product launches, seven product launches in the new year over the course of 2021. We're looking to continue to grow in that particular business. Pelvic health, we're back on track, particularly with our InterStim Micro device and capturing share and we're responding quite robustly. One other comment there is we have now a technology that's very far along, that's in development, for tibial placement. This is going after a different area, simpler procedure, more straightforward. We are now in discussions and working with FDA on next steps for that particular solution. We think that's an exciting opportunity, particularly with the number of patients that don't go on and seek therapy. Ear, nose, and throat, our ENT business. We had our new NIM Vital launch and the Ai Biomed acquisition, PTeye, for thyroid procedures. Really a number of technologies launches and really when we get to neuromodulation, which we'll hear about next from Dave Anderson, it's really been a renaissance across neuromodulation. Our company has been kind of a share donor for the last number of years, and we have new launches, new technologies, and new capabilities that the team will talk about today. With that, I'd like to turn it over to Dave Anderson. He is the President of the neuromodulation business for Medtronic. Dave? Thanks, Brett. Next slide. As you shared, we're going on the offensive with innovation and evidence like never before. We're seeing that turnaround already with recent launches with Percept and DTM, that's just the beginning. In each of our businesses, we have a strong cadence of therapy innovation. In DBS, it's about creating a new standard of care. With BrainSense, combined with our sensing-enabled directional lead platform and ultimately having adaptive DBS, we are transforming the treatment of movement disorders. In spinal cord stimulation, we have the most compelling therapy for back pain relief in DTM, are adding a recharge-free platform with Vanta, bringing closed loop therapy with ECAPs, taking these therapy innovations across multiple new indications. In interventional, we are innovating as well, including a next generation ablation system and new solutions to intervene earlier in the care continuum. In total, we have an unmatched pipeline of therapy innovation across the care continuum in multiple diseases that will drive growth for years to come. Next slide. Our innovation and evidence strategy is the foundation of growing and winning in large under-penetrated markets. We will take share in our larger, more mature markets, accelerate growth in low-penetrated markets, and enter new high-growth markets and indications. The growth opportunity is significant, from both winning in our current businesses to entering new markets and indications that will more than double the size of our existing markets. Today, we'll take a deeper dive into two of our businesses. Brain Modulation, led by GM Mike Daly, and Spinal Cord Stimulation, led by our GM Charlie Covert. Let's start with DBS and Mike. Next slide, Mike, take the lead. Thanks, Dave, and thank you everybody for being here today. Next slide, please. A couple of years ago in Vegas, we were here talking about transforming our portfolio, and it seemed a long way away. That transformation is well underway now. Dave mentioned Percept and talked about BrainSense. That's really our play long term, is we believe that we're going to change the therapy with sensing. Percept is on the market now. It's making a difference and doing well. Next up will be SenSight. That is the directional lead system that is optimized for sensing. Not only are we getting into directional leads, we're getting in with a differentiated product that's also optimized for sensing like nobody else. After that, we'll be coming out with Percept RC with BrainSense, which is the best form factor of a product in the whole space, and that will also have sensing as well. After that, we are looking at aDBS, that's where we really change the therapy. Next slide, please. Speaking of aDBS, we had an exciting milestone in December where we had our first enrollment in the ADAPT study. The ADAPT study really will unlock the market access to first-ever patient-tailored DBS therapy that adjusts the therapy in real time to patients' needs. That is just completely different than just devices. That really is therapy evolution that hasn't been seen before. We couldn't be more excited. It's a global study. There's 12 sites in the U.S. and Europe. They'll enroll about 100 patients with an endpoint enrollment of 36. The first enrollment was with Helen Bronte-Stewart at Stanford, one of the preeminent sensing experts in the world. Next slide. If we go back to the devices. When I said that we have the sensing device around the corner, I really meant around the corner. We will see sensing-enabled directional leads in Europe, we believe early March. That is much ahead of plan. That's ahead of the plans we told you in the past, and we're very excited about that launch. We believe about a quarter after that, we'll see that product in the U.S. as well. If you go to the right of this slide, I think what you really see here is a completely different vision of what this space looked like before. I think you could have flipped it around the other way a few years ago, that we had some of the dots that weren't filled in. When you look now straight up and down, we're the only ones with BrainSense, the only ones with 3T MRI. We have a smart battery that's not matched by anybody, the digital diary driven by open loop sensing, and now our optimized for sensing directional DBS system. We really believe we've fully transformed the product line now, and we'll see significant return on that. Next slide, please. If you wrap it up in what we're doing now and where we're going, we've got a cadence of technology now that is consistent and it is ongoing. We will be launching stuff every 12, 18, 24 months. You'll see new technologies coming from us for the foreseeable future. BrainSense technology will be the key to all of those launches. We'll see that in everything we do moving forward. It's what we believe will make a difference for patients. It'll make a difference in the therapy, and it'll also make a difference in our position in the marketplace. I think Dave said at the beginning about technology and evidence, that that's where we're going. That's how I'm going to close. ADAPT is about the evidence, and we've gone through the technology. The technology is just about here across the board, and we couldn't be more excited about our future. I'll hand off now to Charlie Covert to talk about the pain business. Charlie? All right. Well, thank you, Mike, and thanks to all you for joining today. My name is Charlie Covert, VP and GM of our pain business. Why don't we advance to the next slide, please? What Dave Anderson articulated, and Brett Wall as well in our opening, we are truly undertaking a transformation in our spinal cord stimulation business with a clear path to market leadership. Really a deliberate therapy innovation that matters, based in rigorous scientific research, supported by evidence that reaches into new untapped markets. I'm going to talk a little bit about each of these today. I guess it's only fitting that we're here kind of at an anniversary. It was about this time last year, as many of you probably recall, that we announced the acquisition of Stimgenics, which really initiated our commercialization of DTM SCS therapy, which I'm featuring here. As many of you are familiar, DTM SCS is our proprietary multiplexed algorithm that coordinates multiple signals at multiple anatomic targets. It's really the first spinal cord stimulation therapy intentionally developed from a novel scientific concept, and now demonstrated in an RCT out to 12 months. I got to tell you, our 12-month results are changing clinical practice today, and I'm going to make a couple comments on that shortly. Just to summarize, DTM has recorded the highest back pain responder rate across similar RCTs in this space, with 84% of patients achieving greater than 50% relief. Seven out of 10 patients experience profound pain relief, which is really kind of a measure of magnitude of the pain relief that these patients have experienced. Patients with DTM observed low sustained back pain with VAS scores under two out to 12 months. If you're able to attend this afternoon's plenary as a part of the NANS program, you're going to hear a deeper review on this in the impressive 12 months results that we've put forward with DTM. Of course, it's with these data that we continue to see strong interest in adoption from clinicians in the marketplace. I'll say that this is best evidenced in our business by the positive trialing in de novo implant growth that we've observed since launch and continue to observe even today. The majority of our incremental de novo implants are coming from competitive accounts, which is very encouraging when we think about the trajectory and where we intend to take this business in the future. A quick note down in the bottom hand right corner. Before I advance, I'll just call out for Saturday morning. You're all welcome, obviously, as part of the meeting, to join us at our symposium. We're going to have a breakfast time symposium where faculty are going to share also some of our 12-month secondary outcomes at that time. Next slide. When we combine the outcomes that I just discussed, that we observed with DTM now out to 12 months, proven only on Intellis with the cutting-edge technologies of the rechargeable neuro stimulator itself, we really see our system as unrivaled in the market. Intellis is the smallest neuro stimulator on the market. We power it with OverDrive battery technology, which is proprietary to Medtronic. It's technology that charges in under an hour, and in nine years, it maintains its capacity out to 95%. We stand behind it with a nine-year warranty, as you can see front and center in the middle of the screen there. This is regardless of the patient settings on the device. Snapshot reporting, we've talked about that in the past, powered by our AdaptiveStim technology, changes patient conversations. It moves us away from the subjective discussion to one that's more objective in evaluation of functional metrics, where we can look at seven different body positions measured by the device. SureScan MRI technology is a leader in the industry with broad access to full body MRI. Finally, our Intellis electrode redistribution technology gives us the ability, or clinicians the ability, to refine stimulation between the electrodes in the system. Again, when we put it all together, we really do see our system as unmatched. Next slide. As we shared back at Investor Day, we're really moving to apply our SCS technologies and outcomes beyond the core FBSS market to expanding clinical populations. We see significant upside, as reflected here in the market opportunities across each of these populations, nonsurgical refractory back pain, painful diabetic neuropathy, upper limb and neck, especially given the low penetration rates that you see here today. For nonsurgical refractory back pain, there are two RCTs that have begun enrolling, one's in the U.S. and the other in Europe. We expect both studies to have initial results available in early calendar year 2022. For PDN, we're planning to begin enrollment in our clinical study here in the second half of calendar year 2021, and our initial results plan to be available in calendar year 2023. Then for upper limb and neck, a feasibility study now enrolling, but looking toward an IDE that we're planning underway as well. In total, our expectation here is a shift upward. I mean, we're really making the investment in this space to move toward a higher single-digit growth market with our total SCS business. In each of these spaces, we see clear and isolated double-digit growth opportunities as we move into our commercial phases and establish reimbursement across all three indications. Next slide, please. All right. I'm going to close out my comments with a real clear message. Our innovation pipeline in the pain therapy space has never been stronger as we look ahead to capturing the growth opportunity that I just laid out for you. In the back half of this calendar year, we're planning to launch Vanta, our new recharge-free system. We have clinical efforts and program underway right now to actively evaluate novel energy-efficient therapy, and we're looking forward to sharing that with you and the outcomes of this work later in the calendar year. We're introducing technologies from Intellis on that platform, Snapshot and AdaptiveStim, which I referenced earlier also. I want to make a comment here on the recharge-free market, and this is important. For the U.S., our largest market, Medtronic has been a low single-digit player in recharge-free, and this market accounts for about a quarter of the total SCS market here. Just want to be clear that we see this segment of the market as truly incremental for our business, and we're looking forward to this launch in the back half of the calendar year. As we look to our next generation rechargeable platform, we're really excited to share more today with you about our revolutionary ECAPs closed-loop therapy. Geoff commented a little bit earlier on this this week. This is really something that we believe will shape-shift the spinal cord stimulation space. We're going to host a short, dedicated exposé on this topic today with you, conveying what ECAPs is, why it's important, aspects of our proprietary approach, and really a broader vision of the future. I'll mention that we're advancing with very strong pace right now toward FDA submission here in the second half of the calendar year with this technology. I'm going to welcome Abhi Kulkarni, who's the VP of Neuromodulation R&D to kind of lead us through ECAPs and the vision we're establishing toward autonomous therapy with this technology. Just a final mention here before I make the transition, we're happy to provide references on our scientific submissions here at NANS on ECAPs, we have several. We're proud of that work. Also, as part of the symposium on Saturday that I referenced around the DTM secondary outcomes, we're also going to be featuring Dr. Krishnan Chakravarthy, who's going to share his perspective on the future of spinal cord stimulation, providing really a clinician's lens on some of what we're going to talk about here today. On that note, again, thank you all for joining. I'd like to turn it over to Abhi. Thanks, Charlie. I'm really looking forward to presenting on this very exciting topic of ECAPs and their application in SCS therapy. Can we move the slide, please? As we all know, SCS therapy involves the delivery of electrical stimulation by way of electrical pulses to the spinal cord. The spinal cord itself is comprised of nerve fibers that communicate via these bioelectrical events that we call action potentials. Consider this an SCS system configured to deliver stimulation to a patient. That's shown on the picture to the left. The middle panel is a representation of the anatomy local to where the SCS lead is delivering current to the cord. It's just a cartoon representation of that. When a pulse of electrical current is delivered to the cord, what it does is it activates nerve fibers, and each fiber generates an action potential. The summation of these action potentials is called the compound action potential, and because it is electrically evoked in this case, it is often referred to as the electrically evoked compound action potential, or ECAP for short. A typical ECAP is shown on the far right. It has a characteristic shape. It has this characteristic triphasic shape. An ECAP has a few attributes. What it is, it's a very direct measure of neural activation. The higher the current level you deliver to the cord, you can imagine more of the electrical field now couples to the cord, and it activates more nerve fibers. More action potentials are generated, and so consequently, the amplitude of this ECAP grows or is higher. There are other attributes of the ECAP as well. Its shape or morphology that can shrink or dilate. There are latency effects where post-stimulation, there could be time delays. These other attributes are related to and give insight into the underlying biochemical processes of the spinal cord. Next slide, please. There have been a lot of advances in SCS stimulation therapies over the years. Our own DTM therapy, as Charlie mentioned, now leads the pack in terms of outcomes. Stimulation levels used in all SCS therapies are programmed by clinicians, and the goal is to achieve therapeutic benefit for the patients. Patients have a range of stimulation levels that defines what is referred to as their therapeutic window, and stimulation below the lower limit of this window is not therapeutically effective. While stimulation above the upper limit of this window would cause overstimulation or a sensation of discomfort. You consider the two graphs panels on the right. The area shaded white is the therapeutic window. This is the window within which stimulation current levels will achieve therapeutic benefit. The area below it that is shaded blue represents levels that would have a subtherapeutic effect. The area above, which is shaded red, represents stimulation levels that would cause discomfort to the patient. Now, the therapy level or what we call dose is set by the clinician to a level within this therapeutic window, and it's represented by the green star in these panels. The setting of this dose clearly is important because it establishes that level of neural excitation that would provide patients with pain relief. Now, it's important to realize that this dose that is set by the clinician assumes a constant coupling of the stimulation current to the spinal cord. As long as this coupling is constant and remains the same as in the clinical setting, the stimulation levels that have been programmed represent the right therapy setting for that patient. There are several factors that can impact this coupling. Let's consider the most obvious one, which would be just routine movement by the patient. In that first graph on the right is a representation of how neural excitation can vary as a function of postural changes by the patient. This is a patient who has been programmed to receive a fixed amount of stimulation current. That's the green star there. A fixed amount of current is being delivered to this patient, but you can see that there are several epochs of time where because of postural changes, there are excursions in neural excitation that exceed the upper limit of the therapeutic window. During these epochs, the patient would experience discomfort or overstimulation. Rather than experience this discomfort, what is likely to happen is the patients will turn their stimulation down, and that is represented by that orange star in the panel. While doing this reduces the instances of overstimulation, they now risk not getting adequate stimulation in other situations, and they lower the amount of pain relief that they may experience. What has happened basically is that a very carefully programmed therapy setting can end up becoming suboptimal because the stimulation paradigm itself is blind to this variation in neural activation being experienced by the patient. Of course, the consequence of suboptimal outcomes is, amongst other things, clinical burden. Patients are going to return for reprogramming. You could even have a failed SCS therapy. A direct measure of neural activation by way of an ECAP gives us an excellent method to control SCS therapy. An algorithm designed to vary stimulation levels so that you maintain a constant ECAP amplitude, so that is maintain a constant level of neural excitation, would ensure that patients experience optimal therapeutic relief, and any excursions in neural excitation that are outside the boundaries of the therapeutic window are eliminated. This is shown on the second panel on the right. For the same postural changes that you saw on the first panel, you see that there are no overstimulation excursions. This is because stimulation levels are now being managed to ensure neural excitation that is constant and within the limit of the therapeutic window. No reason for the patient to turn down their stimulation and compromise their therapeutic relief. A very simple way to think about the value of the control I just described is to consider a very sophisticated cruise [control] feature for the car. Just imagine what open loop would be in a condition where you are driving at night, you have very poor visibility, you have an unknown terrain, but you need to maintain a given speed. It's a real challenge. Closed loop is trying to account for that kind of challenge. Next slide, please. We see advances in stimulation paradigms like DTM, to be a key contributor for the success we are seeing with the adoption of SCS therapy. Advancing these paradigms will remain a key area of focus for us. That's clear. Given the insights that ECAPs have to offer to therapy advancement, we've also carefully considered the addition of ECAP methodology to our therapy solutions. We have developed a very versatile approach that allows us to combine ECAPs with stimulation waveform innovations like DTM, with a goal to give patients the best opportunity for relief with their SCS therapy. Now, the measurement of ECAPs is a hard problem. The ECAP is a very small signal. It's a biological signal, several orders of magnitude smaller than the stimulation current levels that we inject in the cord. This very large therapy signal can confound the ECAP and needs to be separated from it. That is the challenge. That's what we have invested in. We have invested in the capability in our devices to have electronics, to have the exquisite sensitivity to measure these ECAP signals. We have also developed algorithms that can extract these ECAPs and separate them from the concurrent stimulation signal. What makes our approach very unique is that our methods can be combined, our ECAP-based control methods can be combined with any SCS therapy waveform, may it be low frequency, high frequency, and certainly, of course, DTM. Next slide, please. We are extremely excited about the opportunities ahead of us that involve the use of ECAPs in our SCS therapies. We now have a window into the signal transmission that is going on in the spinal cord. It's a window that can give us deep insights into how to manage SCS therapy better. Baseline therapies, we believe, will continue to make great strides as they have in recent years, and we will continue to invest in these. Yet we recognize that all of these therapies are optimized for static conditions, and these are conditions that change as soon as the patient enters the real world. Open loop therapies are just blind to these changes, right? Patients requiring constant reprogramming as they drift away from these in-clinic settings is a challenge. Ultimately, again, the versatility of our methods to exercise closed loop control with stimulation waveforms such as DTM, and for that matter, any future waveform innovations that will happen, is what makes our approach truly unique. How this will unfold is that we will begin offering solutions that ensure dose control, so ensuring optimal stimulation levels. That will be our first set of offerings. We see a greater vision, a vision that will deliver, for example, programming automation, followed by therapy solutions that will have lasting efficacy and durability. Our ultimate goal being the use of closed loop control to achieve a fully autonomous SCS solution. Thanks for your attention with that material. Thanks, Abhi. If we go to the next slide. You can see why we're excited about our innovation pipeline in markets that have tremendous growth opportunity. We're already driving growth and taking share with our recent launches, and we have more to come this year and the years to come. Ultimately, we're redefining what's possible in how we treat these debilitating diseases and creating new standards of care with closed loop therapies. With that, let's transition to Q&A. Ryan, do you want to moderate for us? Sounds good. Thanks, Dave. We'll now open the call to questions from sell-side analysts. As usual, we want to get to as many questions as possible, so please help us by limiting yourself to one question and if needed, a related follow-up. If you have additional questions, please go back in queue and raise your hand again. I'll remind you that if you've joined via the Zoom platform, you can ask a question by clicking on the raise hand button next to your name in the participants panel. With that, we'll pause a moment to assemble the queue. Okay. For first question, let's go to Matt Miksic. Matt, can you hear us? I can. Can you hear me okay? Sure. We can. Yes. I'll keep it to one. I just made on the directional lead for DBS. I was wondering if you could talk maybe a little bit about how you're going to sort of counter detail that against, or line that up against the competitive product on the market. Which aspects of this do you think, other than your longtime leadership in the category, obviously, but which specific features of this do you think make this sellable against the current platform or superior to the current platform? Mike, why don't you take that? Sure thing. Yeah, great question. I think when we showed the chart on the features, what you'll see is that we're matching both with the INS and the lead, at least matching all the features of the competitors, but we have things they don't have. Particularly on the lead, one of the things is that it is optimized for sensing. If you use our lead, which you will use with our INS, you'll be able to optimize your sensing experience. If you're bought into sensing, clearly, this is going to be the lead of choice. For people that aren't fully bought into sensing yet, we do have a completely new lead system. Everything's been improved across the board. If you had one thing that we have that not all the competitors have, but one of them does, is we do have independent electric control, which makes a difference on the lead. Otherwise, what we have is the most modern system on the market that's optimized for sensing. Thanks. That's helpful. Okay. Thanks, Matt. Next let's go to the line of Robbie Marcus. Robbie. Great. Thanks for hosting the event and taking the question. Maybe I'll just ask two quick ones here. One with ECAPs, it's a really interesting technology to layer on to DTM. We've seen Saluda out there trying to do closed-loop for a while with, I'd say, no conclusive long-term evidence. What gives you the confidence that ECAPs can have a meaningful patient response? Then now with the complete deep brain portfolio and soon with directional leads, do you think Medtronic, after basically holding almost the entire market and ceding some in recent years, do you think you'll lose less share going forward, or do you think you can recapture some share in deep brain? Thanks. Thanks, Robbie. I'll start. This is Dave, and I'll maybe ask for additional color from Mike and Abhi as well. On ECAPs, to begin with, what we thought was critical, as Abhi shared, is really being able to add a closed loop technology to the most modern, and in this case, with DTM, the best outcomes in back pain relief. From our perspective, we obviously need to generate the evidence of the additional value that ECAPs provides, but it's significantly different to have a closed loop system with the best waveforms available than to have a closed loop system but be limited in your waveform choices. On the point of DBS, from our perspective, when you bring together both BrainSense capability, the most modern lead technology that's sensing enabled, and then ultimately adaptive DBS, there's really no reason to choose a different system. We look at this as a significant share take over the next several years. Maybe, Abhi, can you add a little more color specifically on why we see so much value in ECAPs when combined with modern waveforms? Yeah, absolutely. I think you said it really well yourself, Dave. What I'll say is that I think when we think about SCS therapy, or for that matter, any neuromodulation therapy, it is predicated on this idea that you are delivering a fixed amount of dose or current that couples to your target. There's plenty of evidence that shows that there is variation that patients experience with that coupling. The evidence will come through a lot of the trial work we are doing. We have done a fair amount of trial work ourselves. We have about five posters, and that's kind of leading evidence to show that there is benefit that patients experience when they get closed loop control. What makes our approach again unique is the idea that you're using a best-in-class waveform, so a waveform that is demonstrating really high amounts of efficacy and then improving the quality of experience that the patients will have with that waveform. Let's go to the next question. Okay. Thanks, Robbie. Yeah. We'll go to the next question. Go to the line of Chris Pasquale. Chris, can you hear us? Yeah. Can you hear me okay, Ryan? We can. Yep. Great. One on the SCS TAM expanders, and then if I could, just a quick one on pelvic. I was looking at that list of TAM expanders and SCS, in particular PDN, which is going to be a hot topic again at this year's NANS. I think I saw you guys peg that market opportunity at a little under $2 billion. Just wanted any color on how you get at that estimate, because just based on the number of patients out there, it seems like potentially it could be bigger than that. Just curious how you're slicing it. You teased the implantable tibial system in the Pelvic business. Anything you could share about the potential timing of a commercial launch or what you think the regulatory path with it looks like would be helpful. Thanks. Thanks, Chris. I mean, Charlie, why don't you start with PDN, and then Brett, if you can share commentary on Tibial, on our Pelvic Health. Charlie first on PDN. If you're trying to share, you're on mute. I can share it too. I got it, Dave. Apologize for that. I was on a mute. You guys hear me okay? Yep. Excellent. All right. Good question. On PDN, as we look at that market opportunity, we start with understanding the prevalence. I'll just kind of walk you through how we think about it. There are 25 million-30 million patients in the U.S. with diabetes. We start there, and then we evaluate what we believe to be the PDN prevalence. Those patients that would kind of qualify as intractable PDN, within that sub-segment, and that frankly can't be treated with conventional medical management. That's kind of the approach at which we took this. Certainly, see an incredible opportunity here to take the innovation we talked about, put it in this particular market, and expand that. Brett, do you want to share on Pelvic Health, or Chris, maybe repeat that question for Brett? No, I've got it, Dave. Thanks. I was on double mute. Whatever I was saying is lost forever. Chris, thanks for the question. A couple things. We aren't sharing the regulatory timeline right now. We're in discussions with FDA. The product itself, effectively, a leadless technology, very simple procedural thing to do. What we're really going after there is this large market of, we think it's as high as 4.2 million people that drop out of a two-drug kind of therapy here where it's ineffective. They just kind of fall out of the system, and they don't go back into therapy. What we think is interesting about this, when you look at the location, when you look at the type of procedure, when you look at the simplicity of it, we're excited about that. We'll be giving you more details here in the coming months, as we continue our discussions with FDA and others. We'll come to you there. We really have effectively a fully developed technology. We've been working on it very quietly for some time. We'll be giving you more color on that as we get out here in the next few months. Okay. Thanks, Chris. To the line of Danielle Antalffy. Danielle? Yeah. Hi, good afternoon. Can you hear me okay? We can. Perfect. Thanks so much, Ryan, good afternoon, everyone. Thanks so much for doing this. I had a question on DBS, really this is a question just about the market as a whole. This has been a market, it's been around for a while. It feels like finally we're seeing a significant amount of innovation here. I'd just be curious about your views on market growth going forward, if we're at the point of a potential inflection, do we need to do more to really optimize the TAM here, if so, what would that be from a, I assume, a technology or data perspective? Thanks so much. Thanks, Danielle. I'll start and, Mike, please add to it. From our perspective, there's tremendous opportunity with innovation to penetrate further. It's very under-penetrated in the teens. As we have the opportunity with closed loop therapy to have better outcomes, we see penetration increasing. Maybe, Mike, you can share some additional thoughts on that. Yeah. There's several things that can make a difference. One is, you're right, with the new competition in the marketplace and three voices, we do believe that makes a difference. Early on, our competition was going through low-hanging fruit, but I think that they're starting to look at market development as well. Dave mentioned the closed-loop, so I won't mention that again. There are things in our pipeline that can make the procedure more attractive, whether it comes from asleep or a few other ways to do the procedure simpler and faster. From a data perspective, we are investigating clinical data that can help drive the penetration of the procedure further in a longer timeframe. Yeah, Danielle, it's Brett Wall, if you don't mind if I jump in here. Hey, thanks for joining us. I know this is like twice in one week for most of you, for everybody on. Thanks for joining us. Yeah, Mike's right. There's a number of procedural modifications that are being worked on and a number of technologies to make the procedure shorter, really less onerous for the patient and simpler. We think that's going to help a lot. I think as people get a little more familiar with it, one of the most terrifying things is doing brain surgery awake, functional neurosurgery. There are centers now, and we believe steps forward is to be able to do this asleep actually helps expand the market as well because it's simpler and more straightforward for the patients. Mike or Dave, if you guys want to comment on that, please do. Just want to make that clear that that's kind of a barrier, and as we move forward to break down those barriers, it helps us convince more people to get therapy. It's a great point, Brett. One of the things we didn't highlight in our pipeline is our procedural innovation, but that's an area that we're working on very closely and collaborating with the capital part of our portfolio as well. Okay. Thanks, Danielle. I'll remind the sell-side analysts that are joined by the Zoom platform, if you'd like to ask a question, please click the Raise Hand button located next to your name in the Participants panel. Next, let's go to the line of Vijay Kumar. Vijay? Thanks, Ryan. I had two quick ones. Brett, maybe one big picture question for you. A lot of details here, but if you look at the entire segment of neuromodulation for Medtronic, given the pipeline you have, what should be the growth rate for the segment? When do you get back to, I guess, is this a high single growth segment for you guys, double digits, when you talk about market share? I guess my follow-up is on the clinical data, I guess, in calendar 2022 for failed back therapy, is that a three-month data, six-month data, or what kind of data do you need to see out of the market or perhaps see an inflection in the market? Yeah. No, thanks. I'll answer the first part, and then I'll turn it over to Dave if he wants to augment that, and then he can talk about the clinical trial, the timing, and the data, if that's okay. Did you have another question, Vijay, or is that it? No, that's it. Thank you, Brett. Okay. Yeah, if we look at neuromodulation, there's really a host of areas that we like about the market. As I mentioned at the top, we've been kind of a share donor here for quite a while. We believe now that we have technology in every single category. If you look at SCS, if you look at pelvic health, and you look at now DBS, that I believe puts us into a share taking mode really across the entire enterprise. If we look at SCS, we kind of see that as with the COVID hangover, it's a little hard to get at, but kind of low single digits moving to mid and then upper over time here as we get the new technology out, we get ECAPs out, we get expanded indications. That's kind of the first piece. If you look at DBS, I know the question was asked earlier about if we're going to get into share taking mode. Our technology is really going to take us there and into share taking mode. It's the best battery, best device, best segmented lead. The real benefit here is starting to move patients towards a more advanced therapy. This advanced therapy is being able to understand the signals of the brain and titrate that response so we keep people in range longer. It'll have, we believe, the pragmatic opportunity to expand battery life because you won't be stimulating all the time. The other thing is, we believe it gives you significantly better opportunities to manage and control that stimulation and reduce side effects, and ultimately, to have a better experience for the patient. That combined with the procedural enhancements that we get and shortening the procedure and doing those things, I believe we can actually get this to grow pretty reliably above our current WAMGR. On pelvic health, it's just a hugely under-penetrated market today. I think we've seen with the introduction of one more competitor, I think that's helped expand the market. We see the market growing still quite rapidly even during this time. We think that is an area that will continue to grow and allow us to achieve fairly significant market growth there, and then we'll participate in that, particularly with an introduction of a tibial device. I'll turn it over to Dave if he wants to make any more specific comments. One last thing I'll leave you with, we think there's a host of white spaces, Abhi Kulkarni, who presented here today, has been digging deeply into that. Abhi really our head of all implantables for our R&D operation. There are some really attractive white spaces. In some cases, there are attractive adjacencies where there's a single competitor that looks very interesting to us. In other opportunities, there's small companies going after other types of diseases through bioelectric medicine, which is effectively what this is. We are going to look hard at those because we think those are areas that are a significant growth potential that frankly, a lot of others aren't in yet. Dave, I'll turn it over to you to comment further. Yeah. On your specific question on the non-surgical refractory back pain and the three-month and 12-month data points, Charlie, probably because you're closest to the actual timelines for those, why don't you go ahead and share that with more specificity if you're ready to comment on it? Sure. Good question. Yeah, the calendar year 2022 data we're referencing will be our first readout. At the three-month point, we'll be obviously building that out over the course of the following year to establish more longevity in the data set. That's the timeframe we're talking about. I think the question also related to what do we think we're going to need to see here to begin to grow this out? I think one is efficacy of the therapy waveform, which I think we've established well with DTM. It's applying it in a new population. From a clinical standpoint, we believe we've got the evidence to support this, it's now demonstrating it in this population and establishing payer coverage from that point forward. As you all know, there are a couple different studies pursued in this space right now, and that will help as well as we work to establish that coverage. Very excited about the opportunity that this can contribute to what Brett described as the higher single-digit range of what we think we can achieve in our expanding opportunity set. Thanks, guys. Thanks, Vijay. Next, let's go to the line of Jayson Bedford. Jayson? Hi, can you hear me okay? We can. Okay. I'd like just to ask a bit of a COVID-related question. The industry seemed to rebound pretty well in the third quarter after what was obviously, and when I say industry, specifically, I'm referring to SCS right now. Obviously a tough first half of the year. Any comments on how much of the 3Q rebound or even 4Q volume calendar-wise was a fulfillment of pent-up demand? Just wondering, post-COVID, do you expect a rush of volume? I'm just trying to get your thoughts on any type of backlog that's building. Thanks. I'll start and maybe, Brett, you can add a broader neuroscience view. Geoff provided a total company update earlier this week, and we won't update in addition to that, especially with just two weeks to go in our quarter and competitors preparing to report. I think overall, obviously there's hotspots that come through, and then that has impact for a period of time, and then we see that release again. Brett, anything from a neuroscience perspective you want to add? No, I think you've characterized it well. We've seen these hotspots around the area, and sometimes they shut procedures down for seven or 10 days. Then the procedures commence again. I think given the last year, kind of what we saw at the beginning, we're seeing really a different approach where hospitals are, I think, first of all, better prepared to manage the situation. Secondly, I think better prepared to kind of phase in and phase out as opposed to kind of a blanket reduction in these procedures. Although there are areas now that I think we all read the news and things like that. I think we end up seeing that. As far as the backlog of procedures, I think that kind of depends on the specific area, and obviously our more acute procedures, that probably won't happen. In some of these areas where maybe somebody's been holding off or waiting, I think we could see some of that come through. By and large, I think we're better prepared to handle it this time. There certainly is pressure that Geoff talked about a little bit during the call there. As it relates to SCS, even under that pressure, we think with DTM and Intellis, we're taking new patient share. Okay. Thanks, Jayson. Next, let's go to the line of Matt Taylor. Matt? Can you hear me, Ryan? We can. Super. Thank you. I wanted to ask a follow-up question on the slide that you had that included epilepsy in the future potential areas. I know you have the approval for the DBS product, but Brett, last time I talked to you about that, it was more of a science project. Could you talk about your aspirations in epilepsy and any color on approaches or timing that you're looking at there? Yeah. Dave and Mike, do you want to take-. Yeah, I'll start. Yeah. In addition to our DBS business, we also have our laser ablation business with Visualase. What I'd just say in total, though, is you just look at the debilitating disease that epilepsy is, the prevalence, the million drug-refractory patients that there are. We just see tremendous opportunity to treat these patients more effectively. I won't go into specific product details here, but as we look at our roadmap and the ways that we can treat it, we see ourselves investing more in this space and then being able to provide better patient outcomes that also drive business growth. Okay, great. More to come on that, basically? More to come. Yeah. Okay. All right. Thank you, guys. Thanks, Matt. Next, let's go to the line of Josh Jennings. Josh? Thanks, Ryan. Appreciate it. I was hoping to just ask about ECAPs and wanted to just hear about your expectations for fast followers as in any details you can provide just on patent protection and just the engineering hurdle that was cleared. This has been an ongoing project internally for multiple years, and do you feel like just the secret sauce inherent in the algorithm or in the sensing technology will create a moat? The second question is, a competitor talked earlier this week about another indication. For SCS being chronic limb ischemia and wanted to hear your thoughts on that opportunity and if Medtronic is ever thinking about pursuing that market expanding indication as well. Thanks a lot, guys. I'll start a little with ECAPs and ask Abhi to add some more of the moat technical perspective, if you will. Where I'll begin with is sensing and closed loop therapies has been a more than decade journey for us, and it's hard. To begin with, this is not an easy challenge to solve. The unique capability of being able to bring that sensing and closed loop to modern algorithms and all the therapeutic waveforms that we'd want to use. That's really, from a differentiation standpoint, why we think it's difficult for fast followers to even be able to have closed loop therapy, much less have it at our effectiveness. Abhi, maybe share a little more precision on sensing and the challenge and why we think we're different. Yeah, sure, Dave. We have developed some fairly proprietary methods to combine the measurement of ECAPS and using them to control stimulation. There are two different problem statements here. One is the measurement of ECAPS. By themselves, you can measure an ECAP in any number of ways. The challenge is that when you have complex waveforms, and complex meaning more than low frequency, there is a very critical confound that you have to deal with, which is that there is all of the stimulation, all of that coupling in the cord needs to be separated from this small biological signal that you're trying to measure. The biological signal has a lot of relevance, you need to get that out very cleanly. Our effort has been in trying to just make sure that we can have a very accurate and sensitive measurement, in the presence of stimulation complexity. We feel that it is going to be well-protected in terms of IP. I think the idea that others can measure ECAPs, there is no doubt that there'll be many who will get into this space. I think what will remain complicated, I would say, both by way of protection as well as kind of the art that they have to pursue themselves, is the idea of measuring these small signals in the presence of kind of the stimulation itself, which as it becomes more complicated, you need to just have techniques that are different. I think that's been our investment. It's been a multi-year investment. Thanks, Abhi. Maybe I'll add on the chronic limb ischemia question. The ability for SCS to improve circulation, for example, is something that has been studied in the past. What I'd say overall is beyond the three new indications that we've shown that we have RCTs either underway or beginning soon, we are certainly looking at additional indications as well. I won't go into specifics on which additional ones, but there's several that we're considering, and it's just a combination of what are we researching versus moving into feasibility studies versus ultimately moving into RCTs. Okay. Thanks, Josh. Let's next go to the line of Larry Biegelsen. Larry? Good afternoon. Thanks for taking the question. Just one for me on ECAPs. Can you talk about the clinical data that you're going to be filing with? For those of us who haven't seen the five posters here, what do they show? Is that kind of what you're going to be going to market with, or is there a randomized controlled trial you're planning to do? The DTM results were good. Where do you see room for improvement with ECAP? Can you be specific about what endpoints you expect to improve upon? Thank you. Thanks, Larry. Charlie, why don't you take that? Yeah. I'll say simply, Larry, that we're establishing that clinical path right now. The evidence you're going to see at NANS across, I think we got about seven posters, a couple prospective posters and five clinical posters, really starts to highlight the human clinical experience we have. Last year, we presented some of the sheep data on our early animal experience, and we've been building on that now over the course of over the last year, and we've got now over 100 patients with acute ECAPs experience. We're working that clinical regulatory path now and that approach to how we'll establish with the FDA, and I think we'll be coming back to you with more information as we land that plan. Thanks for the question. Thank you. Thanks, Larry. Next, let's go to the line of Rick Wise. Rick? Hi there. Rick, we can't hear you. Can you unmute? Okay. How about that? There, now we can hear you. Okay, great. I wanted to start with a bigger picture question that leads to a more focused one. It's sort of a two-part question. At the Investor Day, listening to Geoff's messaging about a new, energized, more competitive, more share taking focused Medtronic. We all heard that messaging. I'm just curious, and I'm asking every chance I get when I have the good fortune to speak to folks at the division level, how is that impacting you, your business, your actions, your decision-making? I'd just be curious to hear any thoughts or color or reactions in general. More specifically, on the share taking and growth acceleration front, how are you positioned with the sales force at this point? Do you have the right size sales force? I ask this question because I'm just imagining that you can have great technology, but obviously you'd have to have the right people, the right team, a large enough team to sell it. Are you in the right place? Do you need to expand? Is the team all prepped to talk about the messaging with this? As I reflect on the year or two ahead, are you positioned to take this technology and show the growth and share gain acceleration that you aspire to? Thanks so much. Rick, thanks for the question. If you don't mind, I'll kick it off and then, Dave, maybe I can kick it over to you for your impressions about that across the enterprise. I always tell people that, first and foremost, this doesn't happen because we decide to do something, we snap our fingers, and it changes overnight. I don't think we're naive enough to think that. What I do think is that there's a couple of things. When you make a change like this culturally, we've always had a great mission, we've always, I think, had a wonderful association where we drop everything for a single patient. Every single patient matters at Medtronic, and that shouldn't end, it shouldn't stop. I think on top of that, though, infusing with this desire to compete, hating to lose, kind of not having an internal focus, which we've had for a long, I think, for quite a while. One of the things at Medtronic that I observed coming in was that if you were a good plan negotiator, if you could negotiate a great plan, even though maybe the external market was growing a little faster, and you had a good plan, and you grew to that plan, that was considered successful. I think what Geoff is bringing to the forefront is that mindset is no longer allowed. We're pushing that out. We have a lot of data on the marketplace, and the expectations we're working through are very clear for each business. The other thing that Geoff told me when I took his role, and I know some of you have heard this before, so I apologize, and Rick, maybe you have as well, but he said, "Don't forget what you hated about the large corporation when you were running the business." One of the things, hate's a strong word, but one of the things I disliked was not really being given the levers and I fought hard for them and probably fought harder than most. Having the levers of being able to make my choices or the business could make their choices within the P&L to operate with what they wanted. In this new model, that's what we've done. We've pushed down those decisions into the operating units, and now they make those decisions. Now they still have targets, like every other business, but they can make the trade-offs as they go. Look, we do have strong sales forces and great presence in all of these different fields. Like a lot of things, in a lot of businesses, we will be evaluating and making certain we're structured correctly. In some places we've made some structural changes already, and there will probably be some more to come as we look at that. At the same time, we will be constantly evaluating the talent. In some of our businesses, we've already made those moves, where we've made talent switch outs and changes along the way. I don't want to speak for you, Rick, but I think the underlying question is, basically what you said is, are you even really positioned to do this? If you just kind of change the strategy, but the structure underneath can't support it, then you probably won't make it. There is a very, I think, passionate and strong and dedicated focus on this. My background, a few other people, Bob White, some others, so we came from those environments. I think culturally, those are the push that we'll make and get us through, and I'm excited about that. I'm excited about that change. Frankly, I think our teams are. I think you could categorize it in three ways. There's probably some folks that are trying to figure out, okay, this is very different. How do I work in this? There's probably a few people that liked it the way it was and probably won't come along, and that's fine. They'll have to work somewhere else. There's a core group of people, which is pretty sizable, that said, "What took you guys so long? We're ready to go here." Dave, maybe you can comment on that and bring your own experience to the forefront here. Thanks, Brett. I think you characterized it well, what I'll just maybe add is some proof points from this year. If you look at pre-COVID, we were right on the cusp of launching DTM and Percept. We had a very robust launch plan that was not a COVID-related launch plan. Just seeing the speed and the sense of urgency that the entire team pivoted to have a virtual launch plan and to then go execute that plan and literally have dozens of webinars, educate thousands of clinicians across two very compelling, yet scientific, and in some cases, there's complexity there to educate on. Just from my perspective, an early proof point example of kind of taking this competitive, bold, decisive, act with urgency mindset is how we've all launched this product differently. We've all had to adapt to a different environment. Thank you very much. Thanks, Rick. We've got time for one more question. Let's go to the line of Calvin Xu. Calvin? Hey, can you hear me okay? We can. Awesome. Thanks for taking the question. I'm on for David Lewis. Just a couple quick follow-ups on ECAP. With the back half 2021 submission, I just wanted to clarify, when should we actually expect to see the ECAP sort of pivotal data? Is some version of this going to be part of the seven abstracts kind of presented at NANS? Just on revenue contribution potential rollout, is it fair to assume it'll be kind of a FY 2023 rollout? Thanks so much. Yeah, thanks for the question. We're not going to provide further detailed guidance on timing and revenue at this point. That'll be something we'll continue to unfold as we hit more milestones. At this point, we're just giving guidance on our submission timing. All right. Thanks, Calvin. Want to thank everybody for joining us today, and thanks for the questions. If any of you have any follow-up questions, please reach out to me or a member of my team following today's call. I'll remind you that the slides and replay of this call will be available on our website, investorrelations.medtronic.com, later today. Thanks, everyone, for your continued support and interest in Medtronic and our neuromodulation business. With that, wish you a good weekend, and we'll conclude today's event.