Hello, my name is Eric Sosemski. I'm the director of vascular intervention at Beth Israel Deaconess Medical Center, and today I'll be talking about a case in use of the Medtronic Simplicity Spiral Renal Denervation System. These are my disclosures. I am a consultant for Medtronic as well as some of the other renal denervation companies, including ReCore and Sanovi. So, on the agenda for this presentation is a little bit of overview on the technology, my procedural approach to renal denervation. I'm going to show you a few minutes of a case in a box and talk through that, and then some contemporary outcomes and future directions for this specific platform and renal denervation overall. So, I think it's really important when you think about your devices and how to treat consistent and uncontrolled hypertension with renal denervation to go back to the mechanistic underpinnings of the anatomic variance and consideration. So, here I'm showing you the ganglion in yellow, which supply the renal nerves throughout the renal vasculature. AR here is renal artery, and then you can see in stars, accessory arteries. And it's really important to remind ourselves that what we learned from prior failed trials is that the main renal artery has some variation, even from patient to patient, in terms of how much of the innervation occurs approximately. A lot of times, the renal nerves actually innervate more distally and in higher density and closer to the circumference. And so, when we're thinking about where we ablate, we're really focusing in contemporary treatment and particularly with the simplicity spiral catheter on the branches and in the distal portions as well as the accessory arteries. We know that late arriving nerves are really important variations and anatomical differences for people, which can impact the overall outcome and efficacy of this procedure. So, again, looking at the slide here, we can see up to 60% of patients have nerves that join quite late. Again, the more easily approachable because they sit closer to the lumen and in higher density. And we can't forget accessory arteries as these also have important, significant innervation. Now, this is the renal denervation spiral simplicity catheter. You can see it's really, as I say, dummy-proof for the operator. The older version of this, the flex catheter, had a single electrode that you had to march around to get ablation. But here, we have four electrodes that allow for circumferential ablation in four quadrants. And they work by a little bit of a different spread in energy so we're not circumferentially just ablating in the same area, which could lead potentially to constriction and issues. But it's spaced out so we're ablating in four different quadrants, not overlapped, but still getting all representation of nerves for that vessel. This is a single SKU item. So only one device treats vessels from three to eight millimeters and, again, can go deep into the vessel, approximately accessory arteries with the same device. And then what's very smart about this device is the feedback. Again, there's a generator here where we can get feedback in terms of unsafe thermal energy ablation, making sure that it is responsive and allows for a very safe procedure, which is absolutely essential when we're treating a new condition, hypertension with interventional techniques. I just want to point out here, I'll go through the equipment in a little bit more detail in a minute, but you can see the generator here on the left where you plug in the catheter. And what's unique about this catheter also is its size is dependent on the diameter of the vessel. So you can see that at a larger diameter, in this case, five millimeters, you're going to be hitting a little bit of different length, less length than if you have a smaller diameter and the device is spread out. So you'll notice that you might do more ablations in the proximal vessels where you have more circumferential orientation of the catheter and then a smaller ablation zone compared to in the smaller vessels distally where the catheter splays out a little bit more. Also notice there's no occlusion of the vessel at all during this procedure. So there's always renal flow, which is also keeping it safe and make sure the heat doesn't create any damage to the vessel with this design, which I think is worth commenting on. Now here's the catheter itself. It's 117 centimeter working length. It's an RX catheter. So easy to use either with one or two operators. I get asked a lot, can you do this radially? And there will be radial catheters coming out in the future. But right now, unless you have a really short patient and you want to go left radial, you probably really need to stick to femoral axis. The good thing is it's a six French guide exercise in French sheet exercise. So it's a pretty low profile access. It's a four French catheter, works on an O and four wire. And so it shouldn't really change anything that you normally do even compared to a coronary case in your cath lab. There's really nice markers at the end of the catheter so you know what's an electrode and then what's actually the end of the catheter so you don't cause any trauma with that. And I will go through again in more detail the generator, but this seamlessly works with the simplicity spiral generator system. Now, this figure, people like to call this the bow constrictor figure because again, you can see that you get circumferential ablation through these four electrodes split out along the whole vessel. But nicely, again, preserving safety and not doing ablation the same target. And as I talk about how to ablate, we really don't want to treat in the same and the same vessel location if possible. So even when we pull out our catheter, we don't want to overlap our ablations because again, we're preserving safety here. We haven't seen any need for late renal artery intervention or evidence of renal artery stenosis. And I think doing this procedure right in the current design is the reason why. So let's walk through the next parts of this. So first I want to talk about the smart responsiveness of the generator. And so what happens here is each of these electrodes have a different sensing and treatment zone. So they're looked at differently on the console. I'm just showing you one of the electrodes here, number three in blue. And what you'll see here is that initially the power ramps up to find the right temperature. So it's looking for some feedback from the catheter to say, are we generating enough thermal energy to ablate the nerves that are sitting in that fatty tissue around the artery, but are we not getting too hot that we're going to cause damage? Or on the other hand, that we're not getting enough thermal generation of energy, enough temperature rise that this is an ineffective ablation. And so the electrode will tell you if you're too close to the vessel, the vessel is too small, it's spasm and you're creating too much heat, it'll shut off. And only the one that won't shut off all of them. On the other hand, it'll tell you, hey, listen, we don't have enough contact. You know, the patient moved or the vessel is not in good contact with the electrode and it'll shut off because you're not making, you don't have enough temperature rise, you don't have enough good contact. So here we usually know this within the first 15 seconds. So you can see that initial power ramp. And then once it gets to the right temperature at the power, it will stay there. Now, if something changes, so again, let's say that this vessel starts to spasm, then the power might steep down to maintain the energy that's necessary, the thermal energy, but without necessarily getting too hot. So it'll make that adjustments on its own and won't trigger anything on the system in terms of failure mode, but we'll make sure that you're safely ablating that vessel. Now, this slide, if you have your cameras, you may want to take a picture of, I'm always happy to send you stuff, but this is the stuff that we have in the lab that's necessary for performing renal denervation. Now, the stuff on the top left are pretty intuitive, but just to walk through this, if you don't do renal artery stenting, you might have to order 55 centimeter guide catheters. I strongly recommend getting 55 centimeter guide catheters. You want to be close to the hub of your catheter. They're as cheap as normal guide catheters, and they make all these different shapes in the 55 centimeter length. I typically use an IMA or a renal double curve for more challenging anatomy, but I also have a hockey stick. I don't list it here, but you can see there are several other different shapes to these catheters. I would have an IMA and a renal double curve, 55 centimeter guides available in your hospital. In terms of guide wire, there's not a strict requirement for what guide wire to use, but things that are important, first off, is it can't be jacketed and ideally not hydrophilic, so you want to think about wires that don't have that extra coating. Second, you want some body to the wire, so you definitely don't want something like a typical workhorse wire, but it won't be supportive enough, and particularly for challenging anatomy. You also want a wire that has some directionality of a tip, so like a SpartaCore wire, which I love for peripherals when I do O1-4 based devices, really nice because it's a very atraumatic tip, but you can't select vessels with it, so you need to balance that. The Thunderwire is what Medtronic makes. They're not going to be making it in the future, but that's the wire I typically use right now. BHW is another one, or Grandstand, that people have been thinking about using or have used. On the right here, it's just typical cath lab device equipment, sheath, stopcock, tui. We dilute all our contrasts within the power injector, even when I use the manifold, because most of the time we don't need a full concentration injection just to show where our catheter placement is, so I'd like to save that. And then the bottom stuff is really what comes with the equipment, the Simplicity Spiral Generator and this remote control, which is a reusable remote control. We use just any old bag off the table, whether it's an IVIS bag or ultrasound bag, to bag the remote on the table. And then you'll need to have a generic pacemaker pad or grounding pad to use on the leg for the generator, and this is just the example of ones that you can purchase. Okay, let's talk about the procedural flow. So we're going to go through identifying the renal anatomy, treating our patient up front with sedatives to make sure that they're comfortable, inserting our device, and going through our treatment plan. So again, this is the approach that I think of when I do renal denervation. So first thing, again, if you are not doing a lot of peripherals, doing a really good aortogram up front to me is ideal. I don't do a lot of anatomic imaging at all before renal denervation, so I don't typically do a CTA or an MRA. I'll get a duplex ultrasound if they have risk factors for renal artery stenosis or risk factors for fibromuscular dysplasia, but I don't find that valuable necessarily for understanding accessory arteries or other characteristics of the renal artery. So you're really relying on a good digital subtraction angiography, ideally, or just a power injection without DSA to both look at the renal arteries where they're coming off, looking for accessory arteries and any other pathology that are not on label that we want to avoid treating. You typically want to come from the bottom up by vertebrae, get to the L1 junction, and make sure that you have that lined up there for your picture. I do this usually with either 15 to 20 cc's of contrast, again, all 50-50 diluted, and sometimes I'll make a road map, I'll show you on this next slide here, to make it a little bit easier to engage the renal arteries. So you can see it's coming up here with the guide, and we'll use this just to make sure we get to the right level. This is an essential, but it does make the procedure a little bit more facile. Now again, we're looking at the aortogram to find accessory arteries and also to lay out the renal arteries, but we're going to use the selective angiograms to actually define our anatomy and make sure that we have no anatomy that requires us to exclude the patient. So unlike renal stents where we typically use techniques like no-touch technique or telescoping technique, we do that because there's usually proximal disease that we're trying to avoid aggressively engaging. These are typically healthy vessels, so I don't mind just using my guide catheter to selectively engage and do my selective renal angiogram. Here you can see we're doing this off DSA now, so you can do this just with the normal angiogram. And again, I'm looking for, and I'll show you some images of this, but fibromuscular dysasia, significant renal artery stenosis. Technically, if it's more than 50 percent, you should not be doing renal denervation, and you consider other therapies. And then I'm also looking at the branches. Here on the right kidney, but the panel on the left, you can see a lung, main renal artery, and you can see probably two to three vessels that I'm going to want to treat in the distal branches. So I'm trying to think about that in my head. On the left here, and I'll play this one again, you can see again a nice healthy, let's see if that goes, renal artery with, again, some branches at the end, but maybe less intravenous branches overall. Let's see if I could get that to play again. Yeah, here we go. The other thing to remember is that you want to see the full nephron fill. If you don't see the full nephron fill, you might be missing important accessory arteries. So go back and look at that aortagram. Make sure that you haven't missed anything. If it's filling more than five to ten percent of the nephron, you're probably going to want to make sure it's either intervenable or non-intervenable before you make a decision. Again, I use that term intervenable, meaning that it's three millimeters or larger. Now, here's just some examples of pathology that are currently off-label. So on the top left here is a small aneurysm. Again, I'll leave it to you and your practice whether you treat around that or just don't treat that patient overall, but technically that's off-label. Top right here is fibromuscular dysplasia. Again, ideally you don't want to treat patients who have fibromuscular dysplasia. Maybe there's other therapies that would benefit them more, like angioplasty. Bottom left is kind of diffuse severe renal artery stenosis. The off-label indication is that if it's more than 50 percent, you shouldn't treat with renal denervation. For people who have focal disease, and particularly that's more extreme, like 70 percent, you can stent those, wait 90 days, and bring them back, and then do renal denervation distal to it. So I'm already going to do renal denervation, and they have renal artery stenosis that looks at least obstructive in moderate severe categories, and it's probably reasonable to treat with a renal stent. So then, not only maybe that helps with blood pressure, but also facilitates you doing renal denervation. And so, you know, just keep that in mind, but you have to wait 90 days if it's a fresh stent before you can bring them back for renal denervation. Okay, now that we've treated, it's real, or I'm sorry, now that we've laid off our anatomy, it's really important to get the treatment protocol down. So first off, I usually take a selective angio on the right, then I take the selective angio on the left. Once I've done the selective angio on the left, I want to keep my guide in, and I want to get started. So I get my heparin, make sure that my ACT is over 250. I will not move my guide, and I'll put out my wire, and then I make sure my sedation is on board. So my sedation plan is as follows. When the patient gets in the room, I give them 50 milligrams of IV Benadryl. That gives me a really good baseline, and people tend to be pretty drunk during that. Then I'll give them the normal bolus of fentanyl versed, just like in any catheter procedure. Right before I start ablating, I'll check their sedation level, and I'll typically give them another bolus right before my first ablation. And again, we're going to be treating distal to proximal. Most of the patients that I experience that have discomfort are during the proximal vessels. So when I get back into the main branch, I usually try to give another bolus of therapy, because I anticipate that they're going to become more sensitive as I get closer to the aorto-renal osteum. We've talked a little bit about the equipment and the wires, but the most important thing on the wire is know where your tip is. You don't want to see it really start to invade the parenchyma of the kidney, okay? So you really want to stay within the vessel because if you perf the capsule of the kidney, that can technically take out the entire kidney. There's really, it's really hard to treat. And oftentimes whenever it bleeds into it, it's unsalvageable. So the most important thing with this is to watch your wire and make sure you're not going too far. I often give HRT on nitroglycerin if the vessel looks like it's borderline to make sure I feel comfortable treating it or not. And again, if it's borderline, let's say you're measuring and it's a 2.8, 2.9 millimeters, I typically try to treat it. And if the feedback from the generators, I'm generating too much heat and it's setting up the electrodes, then that's the sign to me that maybe that's not really an intermediable target. But I feel comfortable letting that computer system tell me that versus me making that judgment offline and maybe missing a vessel that should be treated. Now, one other concept here is that you really don't want to bring the catheter into the parenchyma of your kidney. So you got to kind of draw on your mind what the kidney looks like and staying in the hilum and more proximal. So here are just representations of what we would consider vessels outside of the parenchyma of the kidney and what might be invading into the kidney itself. And you can see on the left kidney, the right panel here, that some of these vessels might be three millimeters, but because they cross into the kidney parenchyma, we wouldn't consider them treatable areas. And that's because the heat generated there could actually damage the parenchyma in theory. I've never seen any data or had that happen in my own clinical practice, but again, we want to be safe here and thinking about all treatment considerations. Okay, again, we always going to treat distal to proximal. So I want to deliver this out. I'll treat that distal branch. I'll select each of my branches and make sure that each of the distal branches are treated before I treat back into the main artery. You do not want to overlap your electrode. So you're going to make a little replacement on your image, your reference of where you're treated last, so you can pull back and not have any overlap. And you also don't want to treat at bifurcation. So we know that you won't get good apposition of the catheter or electrode if you're at a bifurcation. So ideally you're straddling the bifurcation or proximal to it if there's branches. Once you've treated everything, you might see some spasm, and we call that notching, basal spasm, whatever. Again, to me, that is just a sign that we've had really effective therapy. I've never seen this be an issue for the patient. I've never seen it be obstructive. I typically give nitroglycerin, make sure that I have no dye hang up, no evidence of dissection. Everything looks good and I move to the contralateral side. I never take my equipment on the catheter. I just pull it back into the catheter, flip the guy back over, make sure I'm selective, and then I bring my wire back out and then my catheter back out. Electrodes. So here are just some of the data you get from these electrodes. So you can see here first that on the top right here, you're getting these impedance levels. The actual numbers don't matter too much. I mean, usually you're between 250 and 350 in regards to making good enough contact for therapy, but you don't want too much contact. So if you're like 400, you might be in a special that's spasming or too small for treatment. Or if you're like 200, you might not be making enough wall contact with that electrode to be able to effectively treat. Now, you could always press the button and see if it works. And if it doesn't, it'll shut off and tell you to re-approximate. But the goal here is you wanna see usually between 250 and 350, and you wanna see a steady line. You don't wanna see a lot of jumping around. So if you go down to the lower panel and you look at electrode number two, you can see that there's some variations here. And that might be that the patient's moving, but also that the contact of the electrodes intermittently against the wall, that's probably not gonna be a stable situation. You may wanna re-approximate the catheter. You could always also make a little turn on the catheter and press in, you know, bunch up the pigtail a little bit more and get better approximation to the vessel wall. Again, each of these electrodes are individually modifiable. So you got four electrodes. You have the ability to take each of these. And if you wanna not treat because you have to retreat an area that the electrode shut off. If you're moving back towards the ostium, you don't wanna treat too close to the ostium within five millimeters, you can turn off the proximal electrode, but it's easily customizable to your treatment zone. Just remember your distal electrode is electrode one. So closest to the tip is electrode one. Now here are some messages from the smart feedback from the system. In the left here, you can see that that was four successful ablations. We define success as at least 45 seconds, but ideally 60 seconds. So we're gonna treat the full 60 second zone. However, if we get only to 45 seconds, we're not gonna repeat that treatment that's considered treated. In the middle panel, you can see what happens here. So in the first 15 seconds, here was 10 seconds, there was insufficient temperature rise. So we wanna see that blue temperature move up. And if it's not gonna hit its zone, then it shuts up that electrode. And it's either because the contact is not sufficient. So that lecture is not against the wall or sometimes the patient moves. So that one, you'll treat the rest of them all the way through potentially re-approximate the catheter. Again, you can push in and turn a little bit and just hold the catheter there and might make better contact. You turn off two, three, and four and only treat one. And then you can get your treatment zone. And then the last one you can see is a warning for a high impedance. So now this one, you gotta check because you either have spasm or too small vessel. And it's important to make sure that you either don't treat that vessel, give some nitroglycerin, but that one might tell you that we're not in the right zones and we have to reposition or just abort treatment of that area. I'm not gonna go into this. These are like the four most common messages, but in your head, it's really only two things. Too much contact, either basal spasm or too small vessel, give nitroglycerin or abort treatment because it's too small vessel, not enough contact. And that could either be because you're just in a position where the electrode's not in a good enough approximation to the vessel wall. I see this the most proximally and you just wanna reposition the catheter or the patient moved and you just have to try to sedate them a little bit more and treat again. Again, 45 seconds successful treatment, 60 seconds is a full treatment, but I think 45 and greater is completed. Okay, let's just look at a quick case before I wrap up. So 53-year-old female, uncontrolled hypertension since she had her first child in her 20s. She'd been on six plus agents, was on five currently, and had some really remarkable blood pressures on five agents, still in the 150s, 160s, confirmed both on her ambulatory office-based blood pressure, so repeated measures in the office, as well as the ambulatory blood pressure monitor. So BMI is that goal, and she's in our hypertension clinic and getting expert care from my partner, Dr. Krawitz. Her labs overall look pretty reasonable. GFR, again, we ideally wanna be in the 45 range and above on label. I personally treat usually from 30 to above, but I think being on label to start your program is really important. We always look for hyperaldosimism, most common cause of uncontrolled hypertension. Hers was normal. And again, because she had some risk factors for fibromuscular dysplasia being early in her age when she was diagnosed, we wanted to do a duplex ultrasound to make sure there was no abnormalities to suggest there. And on the whole meds, I just wanna highlight, she's on clonidine and doxazosin. And again, when I see clonidine, I typically see people who probably have some more centrally mediated hypertension, maybe some overactivity of the sympathetic nervous system. And usually that's a pretty good predictor that we're gonna get a good treatment response or get them at least off clonidine. We've been very successful with that. So here's me in the lab. I'm just gonna go through a part of this. So you'll see, first off, we're setting up our image. We're putting our pigtail, we're counting the vertebrae from above, one, two, three, four, five, getting our pigtail at the level of L1. We leave our lab when we do our DSAs, and you can see here on DSA, that was the image I showed you before. Again, we probably were a touch low here, but we knew we had a good idea of where the renal arteries are coming off to do our selective angiograms. So next we're bringing up our guide catheter, and you can see we're gonna start on the right, and we're gonna take a quick manifold injection, make sure there's no abnormalities. We see a nice, large main renal artery, and we also see some good branching, probably three intervenable targets for us on branches. We then are gonna flip over in a moment and do the same thing on the contralateral side. And you can see my reference image there, so I know exactly where I'm taking off. Now on the bottom right, you can see we have our simplicity generator on our screen, which is really nice. And this allows us both to monitor real-time, but also just to remind us, like for instance here, it says insert catheter. Unless your catheter is outside of the guide itself, you're going to get this message. As soon as it leaves the catheter, the guide, and gets into the artery, then it'll start showing you the readings I showed you before. So here's, again, my IMA guide, just flipping around. I knew they were about at the same level based on my DSA angiogram. And now I'm gonna do my selective angiogram of the left renal artery. And again, here, I'm looking at any exclusion criteria, aneurysm, severe renal artery stenosis, prior stents I didn't know about, and then also making sure that the kidney feels completely. Now you can see here that the overlap in the distal vessels are notable. So once I get my wire in position, I'm gonna wanna find another view. Usually it's a contralateral view to open this up. Sometimes it's an extralateral view. But to try to get some of those vessels a little bit more clear so I know where my catheter and electrodes are going. So here we're making another little puff for ourselves, and we're gonna bring out in a moment our system. Again, just to remind you, we've given Benadryl at this point. We've given the boluses of fentanyl and Versed. We've made sure our ACT is greater than 250. And we're checking the patient, make sure that they're comfortable before we start doing any actual delivery of therapy. So as we go out, we can see now our wires out. We're gonna make sure it's in a safe place. We do not want any challenges with this going into the parenchyma and causing a capsular hematoma. And then this is the thunder wire, which has some body to it. Now look at the screen on the bottom right here. You can see as soon as it left the guide, that electrode started picking up information. You can see the four electrodes at the distal part of the catheter. And then that small dot is the end of the catheter, showing us again that where exactly this catheter ends. We have to pull back our wire before ablation, and this allows the catheter to take its shape. And then we document quickly on a puff here. We save that just to show exactly where our electrodes are so that we don't ablate in the same zone. Now remind yourselves that this is non-obstructive. So there's fluid and blood, I'm sorry, blood and contrast, whatever you're doing, going through at the same time as treatment. And you can see on the bottom right here, we're getting a good drop, a good increase in temperature drop in the impedance. And in the first 15 seconds, this levels out. If we get to 15 seconds, we usually find that we're successful with our therapy. And you can see it's now hitting the full 45 second and going into the full minute mark. As I mentioned before, we're treating distally and coming back approximately, and we're trying to avoid bifurcations. So now we've skipped to the next branch. Again, we're doing all the branches before the main vessel. We're bringing out our catheter. We're gonna pull back our wire. That allows the catheter to take its shape. We document where this is located so we can make sure it says here, store floral completed. So I know where I treated, and then we're gonna deliver therapy. So next, once this is all in place, we're gonna give our therapeutic treatment here and we'll see what happens next. I think we moved on to our proximal one. So now we're moving into the main branch. Now, I don't always need to keep my wire out when I pull back. Sometimes I pull the catheter back without the wire. They teach you to keep the wire when you pull back. But on the bottom right here, you can see that there were two electrodes that didn't fire in the last run. I think we're not overlapped with where our treatment zone is right now, but it says electrode may have moved. So that tells us that there wasn't good contact between the catheter and the vessel wall. So we've done that little quarter turn, and you can see us holding that position of the catheter in my hands, and we're getting more stable impedances. We turn off the other electrodes to make sure that we're not treating in the same zone twice. And now we're getting more stable treatment and we'll be able to effectively treat this zone without any further consideration. So we'll watch that go through its full treatment again, and now we're gonna pull back and continue to march proximally until we've treated everything. Now, let's make sure we get to the end of this before we run out of time for this session. So I'm gonna just skip ahead a little bit, but I just wanna show you guys here now that we're done treating, we're gonna do that proximal one. As I mentioned, we're gonna make sure that the boluses of our sedation are intact because this can be the most sensitive to the patient. Again, you see electrodes may have moved and that's more common in these large vessels. And once we finish treating, we're gonna give nitroglycerin and make sure everything looks patent. And then we're gonna flip over and go to the next side. I'm gonna stop here just for the sake of time, but I think you get a good understanding of this. And I'm happy to go through this live for you in the near future. So in this specific case, we didn't have any accessory arteries. I did one the other day with two accessory arteries and then two main branches. So four total, and we were at like 55 minutes. And here, this is 47 minutes, 85 CC to contrast. We've done 28 cases now. Everybody's gone home sedate. Everybody has used conscious sedation, no additional sedatives or anything. Everybody's done really well. And we've seen some really good outcomes. This patient in particular had a really strong result with meeting her blood pressure goals. And we're able to take her off both clonidine and doxazidin at our three month visit. Just wanna highlight hypertension programs. I'm sure you've heard a lot about this. And our program is absolutely essential. I actually see very few of these patients myself in clinic. And I rely really on my non-invasive hypertension specialist Dr. Kravis and Dr. Kulit, who run our program to the secondary workup, send them to me. And I would say the minority of patients referred for renal denervation need it. Most of the time they can find good regimens for these patients or secondary causes that need to be addressed. And only the minority end up really needing renal denervation. I like it that way. I want hypertension to be better controlled irrespective of a procedure. I love having another option for these patients if we need them. I'm just gonna flip through and show you just a few comments. This is our results so far from our program. These are just eight subjects that have hit six months. We'll be updating this, but we've had a really nice response. And again, there is some variability. Are we getting overall blood pressure changes of 24 over 10 in office, a little more attenuated for the AOBPs, 16 over nine, but overall majority of patients really getting significant blood pressure changes. And again, we don't really measure this at six months. We start to think about this at 12 months and beyond because we know there's blossoming of the blood pressure change that has been occurring as trials have shown longer term data. And so we're watching these patients over time. I just want to end on this. We launched a registry at our research center. We have, I think now we're up to about 20 sites that are participating. It's free of cost. We're in discussion for partnerships with the American College of Cardiology and we follow any device. Patients can be in studies. We're really all inclusive. So if anybody has any interest in participating in this, please let me know. I'm going to stop here, but I just want to thank everyone again for walking through a simplicity spiral renal denervation case. I look forward to seeing all of you in person soon. If I could be a resource to anyone, please feel free to message me and I hope you have a wonderful Sky meeting. Thank you very much.

Medtronic Simplicity Spiral

renal denervation

uncontrolled hypertension

procedural approach

renal nerve anatomy

catheter technology

case study