So, welcome everyone. I'm so pleased that this place is so crowded. I'm co-chairing this session with Vivek Reddy, a longtime friend and wonderful expert, and we have a fantastic panel with Andres Metzner and Petr Pejl. And these three people have experience with this new device, new PFA device. I remember the early days when working with Doron on the Afura system, and there were two things I was pretty convinced about. Number one was that RF was good, but PFA was better. And the second one is that every company would have, at some part of time, a single-shot device for PVI, because at the end of the day, PVI is the only thing, the only ablation strategy we all agree on when it comes to AF ablation. So this is what this session is about. And Vivek, I don't know if you want to have a word of introduction as well? Sure, no, thanks Pierre. I'm also delighted to be here. I think all of you know about the Sphere 9 catheter, the large focal catheter. It's now approved in the United States. You have experience with it, which is very nice. I also remember talking with Doron when we were working on some of the initial first-in-human cases with the catheter, and it was fantastic. But I also remember having a discussion with him, saying, you know, this is great, but, you know, for PVI, it's nice to just be able to be done quickly. And he said, you know, we could probably make this bigger. I remember distinctly when he said that. I said, absolutely do that. And that's what we're going to be talking about today. Andreas is going to introduce the concept of how we went from, or how we got to, single-shot catheters and their benefits and limitations. And then Peter Paiko is going to share his experiences. He was one of the first, and he was involved in the first-in-human studies also, and he's going to talk about his experience. I think you're actually going to go through a case with us, right? So you'll see exactly how the case goes. And I think your talk is about 20 minutes, which, by the way, is about twice as much time as you need to show the case. It should be an interesting program. Thank you, Ivek. So let's get started. I think, Andreas, your first slides are on. Sure. Yeah, dear ladies and gentlemen, dear Mr. Chairman, first of all, I would like to thank Medtronic for the kind invitation. I'm very happy to be here. And my topic is single-shot evolution from cryo to pulse-select, and then SPHERE360, as already introduced. And you all know we are currently facing, and we will face, an atrial fibrillation challenge with increasing numbers, with an increasing, yeah, increasing numbers of AF, with increasing prevalence and incidence. And that means we'll have a lot of patients suffering from AF, with an increased morbidity and mortality, as you all know. And it also means that we'll have to perform a lot of AF ablation procedures nowadays, and also in the future, with PVI, as already mentioned, as the key element of all ablation strategies. And we started about 25 or 30 years ago, as you all know, with point-by-point ablation, RF-based and 3D mapping guided. So we perform point-by-point ablation lesions around the ipsilateral PVs, with the endpoint of acute electrical isolation of the PVs. But you also all know this procedure has certainly challenges. It's a, first of all, a small focal point-by- point catheter that we use, which demands a very long learning curve. It has safety gaps, as we all know. And also means that it's a long procedure, and I would say for only absolute experts. And today, as we all know, we don't have the time for such a long procedure, and we don't have that many experts. And so there was a demand, and there is a demand, for ablation technologies that are easier, that are more reproducible, that are safe and effective at the same time, and also time-efficient. And that's the topic of today. You know that about two decades ago, the CryoBalloon came to the market. It's the pioneer of single-shot devices. The first single-shot device on the market, providing isolation with a single application. And nowadays, it's one of the gold standards. Why? Because we could first prove that PVI performed for the CryoBalloon as a first-line therapy in polycystic AF is much more effective than medical treatment of AF. That has been shown in multiple studies, and we also know from the FIONACE trial, published some years ago, that CryoBalloon-based PVI is at least as effective and as safe as point-by-point RF ablation. And finally, and I think that's also a very striking argument, it's very reproducible. So that results comparing two different centers, both AF ablation, both PVI as the key element, and patients went into a clinical outcome or follow-up for one year after CryoBalloon ablation, after RF ablation. As you can see, the results of the CryoBalloon ablation are very homogeneous. That means that this technology is less dependent of the experience of the operator and of the centers. And that's the reasons why CryoBalloon ablation nowadays is still a gold standard, and I think still with good reasons, however. And it's also something we have to know, there's still a safety gap. That's an analysis of the incidence of esophageal fistulas with point-by-point RF ablation, but also with the CryoBalloon. And you see, it's very low. The incidence with the CryoBalloon is only 0.0015%, but there's still at least, yeah, a tiny, a very low incidence of thermal injury to the esophagus, but also to the phrenic nerve. And that gives also room for new technologies and for new devices. And today, we also have the PulseSelect PF ablation catheter, which is by design, as you know, and as you see, a different catheter. It's a circular catheter, and it incorporates not cryoenergy, but pulsed field or pulsed field ablation. Just to show you the characteristics, it's a catheter with a circular shape with nine electrodes that are, therefore, sensing, ablating, but also pacing. The diameter of the loop is 25 millimeters. It is 20 degrees forward tilted, which makes it easier to position the catheter fluoroscopically guided at the respective PV. It has a nine French shaft and bidirectional steering capabilities. And finally, I think that's very important, it's an over-the-wire technology, which makes it rather easy and very safe in manipulating the catheter within the left atrium. That's how the catheter looks like when positioned at the respective PV. That's the left superior PV. And you will induce four applications at an osteo level. You have to turn it 90 degrees after each application, and later on, you will also induce an anterole ablation by bringing the catheter to the anterole part of the respective PV. And what you will finally induce is very sharply demarcated ablation lines around the Y-level PVs. And I would also like to provide you with some data. That's a pivotal trial that has been published already two years ago with a total of 300 patients, 150 suffering from paroxysmal and another 150 from persistent atrial ablation. Baseline characteristics are not so special. You see, it has been a rather long procedure in the beginning with more than two hours ablation time, but you have to keep in mind it was a study with a study protocol and a waiting period after the last successful application. And what makes it also very interesting, at least for European centers and for German centers, is that you can apply this device not only in general anesthesia, but also in deep and conscious sedation. That's the clinical outcome data after one year. It's in the range of what we know from other PF devices that are currently on the market. So in paroxysmal, we have about 66% of patients being in stable sinus rhythm. In persistent, it's less than 55%. It's a very close follow-up with trans-sulfonic Holter monitoring, with Holter ECGs and so on. So although the system and the procedure itself is very easy and is very short, finally, you can have good results as you know them from other technologies as well. And as we also know from PFA devices, no safety aspects finally. There's no thermal injury to the esophagus, no thermal injury to the phrenic nerve. And whenever you expect good clinical results, you need a high durability of PVI, and it has also been proven for this device. It's two studies that I'm presenting with 25 and 15 patients each. In those two studies, patients have been taken back to the lab after 57 and 75 days, just to check for durability of PVI. And as you can see on a PV analysis, the durability rate was 98 and 95%, and on the per patient analysis, 96 and 93%. So it's a very effective tool, a very safe tool, but still there's room for other technologies, for improvements, and so on. And now I would like to introduce, I would say, a very spectacular tool, which is the CR360 PF ablation catheter. It's, again, an over-the-wire technology. It's a lattice tip catheter with a maximal diameter of 34 millimeters, and you can bring it into different morphologies, as you can see at the right superior part, into a linear, a sphere one, and a disc one. That means you can target a PV inside a PV at the osteum, but also at the antrum. It's a rotation-free ablation, which is also very attractive, with two to five applications per PV, and one application takes only 5.9 seconds. It's a uniform energy delivery from the whole surface of the lattice, and it's, again, an 8.5 French technology. That means you can bring it into the left atrium via a regular 8.5 French transeptal sheath, and it's, again, very important in over-the-wire design. Some more characteristics. There are six bipolar electrode pairs for mapping and stimulation. You use impedance information for estimating the catheter tissue proximity. Again, a single transeptal puncture only, and there are also electromagnetic sensors allowing for tracking the catheter for shape visualization, but also for performing anatomical activation and also voltage mapping. And I would like to introduce the very first study that evaluated the durability of PVI when conducted only and exclusively with a SPHERE 360 catheter. It was already demonstrated and presented by Vivi Gretti last year at the APHS meeting. Indexed PVI in paroxysmal F only performed with a SPHERE 360 catheter with two to four applications per PV. Again, a very close follow-up with trans-telephonic ECGs for 21 weeks following a blanking period of 90 days, and thereafter in monthly periods. In addition, also Holter ECGs have been performed after six months and after 12 months. And, and that's very important, also an optional invasive remapping has been performed in a majority of patients. There's been a primary efficacy and safety endpoint, and secondary endpoints have been chronic freedom from IF, as well as, as already mentioned, lesion durability on invasive remapping. That's the study protocol once again. A total of 100 patients, and you can also see that three different generations of pulses have been applied. 50% of the patients have been treated with the last generation of pulses, and the remapping has been performed in a majority of all the patients participating in the study. Again, the baseline characteristics, all patients with paroxysmal F, and now the very impressive data. Number of applications per PV was only four. Four applications with an acute isolation rate of 100%. That's something we can expect nowadays from a new single-shot device, but if you check for the ablation time, PVI application time in total 1.5 minutes only. The PVI transpired time only 11.5 minutes from the first to the last application, and left atrial dwell time as low as 22 minutes only. A very quick, a very quick procedure. And that's data from, from the invasive reassessment, and you see on a per PV analysis, when only considering the last generation of pulses, 98% of all PVs were durably isolated after 75 days, and on a per patient analysis, 93%. So very impressive data, which also translates into very good clinical outcome data. Actually, almost too good to be true. You see, when considering all the pulses, it's 85% after one year. When considering only the last generation of pulses, with a very high rate of durability, clinical outcome data, yeah, it's very extraordinarily good. Both here, it's shown 100%. Again, PVA devices, there's no safety issue finally, especially no harm based on thermal injury to the esophagus or the phrenic nerve. And so, dear ladies and gentlemen, dear Mr. Chairman, let me conclude. Shaping the future of PVI, in my opinion, means that PVI will be a domain, and is a domain, of single-shot devices. The cryobloon is certainly the pioneer of single-shot PVI, but still on the market, and due to good reasons, I think. PVA has significant benefits over thermal energy sources, and finally, I think single-shot PVA-based technologies will be the future of PVI. Thank you very much for your attention. Okay, now Peter. Peter Pajko is going to share a case with us of the C360. Dear Chairman, ladies and gentlemen, I'll just have to switch to my slides. We had a privilege to be part of this first in-human study that used this technology, and we were also involved in the very early development of the Afera system, starting in 2018, so which is seven years from now. So, let me start with a very brief overview. It was already done by Andreas. Most of it, these are my disclosures, and Afera is available in the United States. I would just to highlight here that it's not only a blader and the pump, but it's a very, very complex and advanced mapping system. It has most of the features that you would expect from the current 3D mapping system, with the annotation of the electrograms, and it allows a very nice creation of activation voltage maps. The Catechery Sphere 360, you can imagine, like a larger version, a softer version of the Sphere 9. It has a size of up to 34 millimeters. It's fully compliant. It has a radio operator marker. It has a magnetic sensor, so the visualization and stability of the tracking within the 3D mapping system is very nice. It was shown it can be conforming the different kind of shapes, but anything in between these discs, sphere and linear, is possible, so it can really be adjusted to the individual anatomy. It has also bipolar electrodes, six pairs, so it gives you bipolar electrograms, which can be used for mapping, for activation mapping, voltage mapping. It also assesses the tissue proximity by measuring local impedance, so it's all done via a single transeptal puncture using Achilles, something which we are all familiar with, so it's very easy to integrate in our kind of workflow. What was already mentioned, this Catechery underwent this kind of evaluation, invasive remapping after 75 days, which is very important for most of the pulse field technologies, because if you don't do it, the reconnection rates are usually high, because the acute isolation is very easy to achieve, but the durability is something which you look for, and the only way how to find out the durability is to remap at one point in time after, for example, 75 days, and if the last iteration of the pulse was used, the very high durability was found. So this is the image what you started with. You can create maps like that, voltage maps, the ablation tags are shown in the 3D map, so generally you can work zero flora, because no x-ray is that much needed. Pulse ablation remaps are also created with the Catechery, and the remap you can see more or less reflects what was just acutely there. So let me show you a case. This was a typical paroxysmal AF patient, which was quite big guy, nearly two meters tall, and I must say this video was never meant to be shown. It's just a very regular case we did during the study. The study is over, so we didn't enroll new patients, but so this is when we did that, we never knew that it's going to be shown. We still like to use eyes, because we believe it's nice to demonstrate where's the carina between the appendage and left vein, so this is the way how you can just optimize the location. This is how the Catechery looks like on x-ray, and generally there are very different ways how to do this. So this is something that most people nowadays use within the study, which was like a mapping on goal. So you just don't create the whole geometry, you just focus on the left side of the veins and the right side of the veins. Again, the eyes image to show you that you can somehow optimize the size of the shape of the Catechery, and to reach the ridge, but maybe not to reach the anterior wall to be too big. So this is the voltage mapping of the left superior. We have a wire inside the vein, and one point in time we were happy with the left superior. We repositioned the wire into the left inferior pulmonary vein, which is not shown here. This is done maybe under the echo, or maybe under the fluoroscopy. So generally you withdraw the J wire from the tip of the Catechery, and you insert it in the left inferior pulmonary vein, and then because you're on the rail of the wire, like this, very automatically you can just go inside the vein, and by expanding, small expansion, you can create the anatomy. And for the purpose of PV isolation, this is good enough to have this kind of anatomy, these veins, and then you can directly proceed to the ablation. As was mentioned, these applications are done in a short manner, so the short time manner, so it's a six seconds, 5.9 seconds applications. So we will start early on with this. So we try to localize what we believe will be a more distant position. So we do this on intracardiac echo, but obviously that echo is not compulsory to use, so trying to find a little bit more distant. We are not afraid to create PV stenosis with pulse field. We know it's extremely safe, and you will see the application started now. You see the noise from the application. So it's six seconds. This was the first application with a collapsed catechery. Immediately all the electrograms will disappear. That's very typical. This is how the application looks like on intracardiac echo. You'll see some artifacts from the application. So this is typical also for all the pulse field technology. You'll see electrograms prior, after artifacts, there is nothing. But we know from the previous studies that maybe more should be done, so we generally withdraw the catechery a little bit, we inflate it a little bit. As you can see at the tip, there is a marker that measures the distance between the previous point and kind of current location. So generally what we aim here is about five millimeter distance. This is maybe too much, and we will come back more inside the vein to somehow compensate for that. Generally what we're trying to achieve is the longitudinal redundancy of the lesion. So having a kind of four applications with five millimeter kind of distancing, it gives you about two centimeter kind of longitudinal redundancy, which is probably very safe for the PV reconnection. So there is a number three application for the left inferior pulmonary vein, and we will do one more just by pulling back the catechery and expanding it. We somehow cover also the antrum of the pulmonary vein. So this is all that is needed. This is no speed up of the video. This is the normal speed. People usually show this with the higher speed. This is the real what was happening. So we cannulated obviously now the left superior pulmonary vein. We again start with more inside position, and after giving first application, we expand the catechery a little bit, and aiming a little bit more five to six, seven, eight millimeters, maybe compensating, then going a little bit more inside with the next lesion, and very easy to perform. So again, more expansion of the catechery to somehow confirm and pushing it into having a good contact. There is a local impedance measurements to give you the contact kind of feedback, but I mean just having this kind of compressible mesh, it gives you quite a good confirmation that you are in contact. So this one was aimed to somehow cover the really antral of the pulmonary vein, or left superior pulmonary vein with some overlap to the left inferior pulmonary vein. So that will be the number eight application, and this is what you need for the left side. So as you see, that was about five minutes or seven minutes of this. We have currently 46 seconds of the ablation time, so now we will do some mapping. You can see also number of electrograms that were acquired, so still we do the mappings with the same catheter, which is very nice because it's all in one solution for the mapping, for ablation, you don't have to exchange the catheters in the sheet. This is the position of the catheter within the right inferior pulmonary vein on echo. So again, we like the echo because you can kind of optimize the position and the sizing to conform with the pulmonary vein. So this was the, again, we just mapped both veins. We put the wire inside both of the veins, and along the wire, automatically, you go inside. So it will take some time. It's not shown, the manipulation with the wire. So this, we didn't record it. We just have this Afera video. And once we are in the wire, in the right superior, as most of the technologies have, you can go inside. I believe the catheter itself is very comfortable, flexible. So it's not a big, stiff balloon. Sometimes, these have a problem to cannulate the right inferior, and it's over the wire. So once you can put the wire into the vein, it's very easy to go over the wire and just have a good position with the antrum. So once you're there, you can start to ablate. We still wanted to fill some of the anatomy. And also, I have some voltage kind of information for later on a remap. We already collected about 700 electrograms mapping points. So if you would spend more and go to fill the full chamber, we would create a reasonable voltage map, not like sphere 9, but still for some of the arrhythmias could be good enough to make a kind of call what that arrhythmia is. So this is the first application for the right superior. It will just be very similar what was on the left side. So we started as we should paralyze the patient. We use the general anesthesia not to have too much movements. But because the catheter is generally inside the vein, it very nicely sits there. And there's usually not any movement during the diaphragmatic contraction, which you usually have on the right side. So let me pull back now. If you have a 5 millimeters kind of distance from the previous location, so 5, 6 millimeters, and there will be another application to follow, to adapt. We have another two to go. So that would be number two for the right superior pulmonary vein. You see the distance, 5 millimeters. This is perfect. This is what we aimed for this. So another 5 millimeters more proximal, enlarging the catheter. Again, as I said, there is no speeding up the video. This is really how the situation looked like. As you can also see there, color coding of different splines of this, or not splines, but segments of the sphere 360. So if you have an electrogram from different parts, you can somehow annotate that and just have an idea of it. If it's, for example, violet color, you can say this is on the posterior wall of your anatomical reconstruction. So this was number three. And there will be number four for the right superior pulmonary vein. Again, trying to aim for somehow to be in good relationship for the previous lesions. And very similar manner will be repeated for the right inferior pulmonary vein. This is, again, the position. And as you see, it's compliant. So it's very easy to get in good contact. So you enlarge it, you push it slightly against the tissue, and it gives you a good lesion. So we have one minute of nine seconds of ablation time. So it's very rapid. Depending how much time you spend on the wiring of the veins and doing the map and remap, you can be pretty quickly. So again, now we will go into the right inferior pulmonary vein. And I will just leave this ongoing because that's the purpose of this video, just to show the whole procedure. As was mentioned, this should be 20-minute talk. And the whole procedure is pretty fast. But this is how it goes. So we started, again, with the smaller sphere or basket. And we enlarge it to go into more proximal. The ACT level for this is about 300. I believe this is what we are used to. I've worked with some of the devices that use high power RF energy. Then you are probably good with the 350. But the pulse field is probably kind of not that risky and thrombogenic. So that 300 ACT level is good enough. So this was the number two. And there will be another two applications in the right inferior pulmonary vein. And afterwards, within the study, we didn't really ablate it on the posterior wall. I believe it would be very easy to do so. The study protocol might edit only PV isolation because these were purely paroxysmal patients. So last one with the really large kind of disk, I would call. But you can imagine that it would be very easy to pull out the wire and just bring it back to the middle of the posterior wall and to finish with this one. So once we did that, this is number 16 application. We just went and revisit the veins just to look whether there is something interesting. And in the left superior, somehow there was this angle that we felt that might need additional one bonus application, which we decided to do. I don't know whether it was wise or unwise. I believe it's safe to do additional applications. We had no problem in this study with hemolysis. So this was the one additional number 17 application. But that was it. And then we start remap. Obviously, acute remaps in pulse field are deceiving because there always is isolation. If you cannot isolate acutely with pulse field, that means you're in trouble in the long term. But it's not perfect. It's not like sphere nine remaps, but still give you an idea about what has been done. And obviously, you look on the electrograms, which are on the left side and left hand of the screen. If you insert the catheter inside the pulmonary vein, you can check for the electrode or maybe dissociated activity. So again, just moving and automatically, it acquires points, automatically acquires volume and voltage in a manner that you would expect. So I'll just keep this for a little while just to show you the mapping. And that was the end of the case. You see that we've done it within these 10 to 15 minutes. And as I repeat, the mean LI dwelling time for the study was 20 minutes, for the ablation was just 10 minutes, which was shown in real time. We'll move on. So this is the case summary. We did mostly four applications per vein in one vein. For whatever reason, in this case, we decided for one more. I mean, six seconds of more pulse field time is not a problem. We were asked to do adenosine to check of the exit block, which was an entrance block, which was shown. The whole fluoro was about five minutes. It can be done zero fluoro. Some of these cases, in the later on, were done zero fluoro without wearing an apron. If you have intracardiac echo, it's very easy because it's 3D integration. You need the eyes to just verify the position of the wire. This was the remap, which is very important just to show that it looks very much what we've done acutely. That is durability there. Upper wall is spared. We see these channels in between the veins. I believe we haven't seen that many from any other technologies of roof-dependent flutters. I believe this is safe, and it doesn't bother me. And I believe it's a way to go for paroxysmal atrial fibrillation. So let me conclude that this catheter allows all-in-one solution, 3D geometry reconstruction, voltage activation mapping, and also, most importantly, pulse field ablation as a single shot. Maybe not single shot, but four applications per minute, five seconds, six seconds. It's still a nice and very effective way to do it. In this particular study that we published, it was very efficient, safe, and effective. And the long-term data, one-year data, published by Vivek later this afternoon. So he will show that. And I may say that looks good now. Thank you. OK. Thank you very much, Peter. As we're waiting for questions from the audience, I share your comment. I'm sure the one-year results are going to be outstanding, given the acute results and the three months, the ability of the lesion. It should translate into fantastic results. I have a few questions for you three, because you have experience of this device. Six segments that can be energized independently, and it's monopolar delivery. So how does it work? Is it segment after segment, all of them at the same time? Do you sometimes avoid delivery on one segment? What is the benefit of this? Yeah. No, no. It's a good question. It's very important for these regional ablation catheters, because it actually cycles through all of the segments. And it's important, because if you deliver it at the same time, then depending on how much one of the, we'll call it leaflets, even though it's not a leaflet, but anyway, one of the sectors, how much contact there is, you could have, let's say, not much contact. And more energy could be shunted there than everywhere else. So I think that's one of the advantages. And I think that's one of the reasons why that Drone designed it that way. Thank you. And you are committed to use paralytics. Is there hope that some deep sedation would be enough with no intubation? Or it's irrealistic? I believe within the study, we used general anesthesia for all the patients. But obviously, this is the next step to go. And because of the balloon, or the sphere is compliant, I believe if you stick it into the vein, and the structure of the sphere is in a way that it sticks to the tissue. So I believe this is the same would be so in the sphere 9, that the way it sticks to the tissue is much better with the 4-millimeter tape because of the structure. Just the footprint stays there, irrespective of the movement of the heart. So I'm pretty sure that maybe the strict paralysis is not needed, because the compliance will give you a very good stability. Yeah, I mean, let me just add to that. Again, all the cases were done under GA in the first human experience. But I think that one of the interesting things, as Peter said, it is somewhat compliant. And it is, in essence, a one-shot technology. So even if the patient moves, and coughs, and does these things, which, by the way, is inevitable, it's going to happen, you should be OK. Yes, your map may not be perfect. But you can see, you saw from the case how quickly it is. You just rewire the other vein, and boom, boom, boom. So I think that, again, it's hard to know until we do it. But my guess is, we'll probably be OK. Yeah, maybe you can also report, we are using, or we used a FARA system with a CR9 catheter now for more than two years at our lab. And we also started in intubation. And that works, obviously, sure. But in Germany, only systems will survive that can be done also in deep or conscious sedation. And so we switched completely, and do now all our cases only under deep sedation. And it also works without any compromise, safety, efficacy, whatever. No map shifts, nothing. Sure, the CR9 is a smaller catheter. You don't apply probably that much energy over a big surface. And you have some tiny movements of the patient. But as mentioned, no compromise for safety or efficacy. So it works quite well. And I would guess that must be the goal also for that system, that we can apply it, at least in Germany, also in deep sedation only. Just one more thing to add, just to repeat. There is a magnetic sensor on board. So the stability of tracking is much superior to the impedance-based kind of tracking. So this is very important to emphasize. So no map shifts expected. Kars? Yes. So thank you very much for the wonderful presentation. You are all experienced users in the SPHERE 9, and now also the SPHERE 360. And when I look at the 360, I think this is super fast. But what I saw from the videos from the PVIs being done with the SPHERE 9, that was also relatively quick. And of course, creating a map with the SPHERE 9 is a little bit more detailed. And you can make a more tailor-made lesion around the veins, because this is a single shot. So you have to wait what sort of lesion you get. And we're still manual artists. We still are skilled artists. And I was really impressed by the SPHERE 9, and really happy, well, maybe I can do this. And now seeing this, I was like, ah, but the SPHERE 9 is also very nice, because you feel like you have a paintbrush in your hand, and you can nicely do the lines. So if you now compare both systems for PVI, and maybe also interprocedural interflutter, for example, where do you see the SPHERE 9, and where do you see the SPHERE 360? Look, everybody is going to have their own preference. Remember, we had RF and cryo, both good technologies, and fire and ice, right? And some people used RF, and some people used cryo. So that's good. But let me make one other important point. We're seeing with many of these technologies, you can get durability. We've seen this in many first-in-human studies. And we've also seen, as it goes from first-in-human to multi-center experience, et cetera, and particularly when you get into general clinical practice, the durability is falling off. So what we need is scalable durability, scalable across clinical experience, right? And I think for something like that, my guess is, I don't think this is a controversial statement, it's very likely the SPHERE 360's durability is going to be easier to scale than SPHERE 9, which, frankly, still takes some technique, right? And not everyone is an artist, kind of. Yeah, I would say, because we went through this point-by-point era, so what I did for 15 years was doing point-by-point ablation. So after 15 years, you get some skill, and you can use any device. But if you never went through this era, you will cryo user, for example, you will love this, because you just bring the wire. If you can bring the wire into the vein, you will have a very nice PV isolation, which is very, I would say, comparable between people that have 15 years of experience, and people that are just as training fellows. I believe that's the big advantage. And we know from the cryo that the difference between the centers can be very much in the point-by-point centers, or point-by-point world. But the cryo just brings some kind of same results all over, because just if you put it there, it will be the same for everybody. And I also think for PVI, I think the SPHERE 360 has less room for mistakes, because you still have to make sure that you have enough overlap from lesion to lesion to keep durability with the SPHERE 9. And with this one, it's a single application covering the whole surface of the PV. And I think, at least also based on our experience, the SPHERE 9 is a great system for everything going beyond PVI. I think PVI will be a single-shot domain, but going beyond PVI, for example, treating atrial tachycardia with linear lesion sets and so on, the SPHERE 9 is just great. And it does not induce that broad lesions as the SPHERE 360 would do at the anterior wall, or posterior wall, or wherever. So I think having both systems for pure PVI and for everything going beyond is great, because they have, I would say, different targets, finally. This is one more thing. I like SPHERE 9 a lot. I think for re-dos, it's going to be probably a sweet spot. But once you start using something as simple as SPHERE 360, you get addicted to it. And that's one of these intangibles that's hard to understand until you actually start doing it. And from a health care standpoint, it makes a lot of sense that, in fact, you maximize the use of the resources you have to treat the most patients that you can. But I mean, your point is well taken, Carson. I think what I would suggest is that we make sure that we train our fellows not only to use those devices, but also to do other type of ablations, like VT, et cetera, where they can acquire some skills that are needed for every EP. But seriously, going around the veins point by point, it's the past, in my opinion. And SPHERE 9 is fantastic. I love using it. If you have a single-shot device, I think 90-plus percent of the doctors will use it over a point-by-point approach. So I had another question, if no one, please. In the meantime, any data on hemolysis using this device? It's a good question. You know, when we did this study, this is before we really appreciated hemolysis as an issue at all. So the answer is no. Look, there is going to be a US IDE study, and I think including Europe, that's going to start sometime later this year. And in that, hopefully we can collect some information. Thanks. Thanks for the excellent presentation. Any experience on posterior wall with this? And also with the catheter, having a small tip in the front, how is contact in the posterior wall? Are you able to lay down a disc on it, or is it going to prevent the contact? Second thing is, if that posterior wall is doable, can you turn off some sectors which are not in contact with the heart, thereby prevent hemolysis? So that's a very good question. As I said, the study protocol required only pulmonary vein isolation. So we don't really know from our experience, but I guess that it will be very easy to do the posterior wall, even if there is this small tip at the end of it. Because still, I believe it's a traumatic. And the posterior wall, we know from the forepal system that can be done pretty nicely. And there is the small tip also in the flower. So I'm not worried about that. Obviously, I'm not worried about the hemolysis either, because it was shown that the system is quite effective, very few lesions. And there's a number of lesions, a number of applications that will increase the risk. But this is something to be elucidated in the further studies and further trials. Thank you. Any other question? So we have two minutes left. Anything you would like to add on the perspectives offered with this new device? Well, one other thing. We didn't really talk about it. And it seems to be less of an issue in Europe. But in the US, there's a lot of interest in doing cases floralists, not wearing lead. And I do want to point out, in the study, we did a few cases just to show that we could, completely floralists. So not wearing lead. Completely floralists. So not wearing lead. Zero floralists. So it is something that I think will appeal to a significant number of physicians. It doesn't come with any dedicated long stirruple shifts, right? You've been using an ageless standard approach. Any 8 and 1 half French sheets should suffice. Any weird position of the cage when compressed or forced against the anatomy? I mean, the Farple's device has this cobra issue that is still there with the Farview, unfortunately. Anything comparable with this one? I'm not. I mean, you could talk. Also, Peter, I'm not aware of anything. Again, we didn't really do anything beyond PBI. The protocol constrained us. So if we try to position another location, let's say more anteriorly, there's a little bit of manipulation you do so that you get to this very flat position where it's bent back a little bit. But it was doable. When we were trying to just ablate sort of anterior to the right veins. If you want to go beyond that and other locations, again, we just didn't do that. I didn't notice any temperature information during the deliveries. Is there any available? No, there's no measurement because there are no thermocouples on the device. Only recording electrodes. Recording electrodes on the tip of the. But we know it's probably non-thermal or just a small increase. If you work with Sphere 9, there are thermocouples because Sphere 9 was initially aimed for a thermal ablation with RF. So if you do pulse field there, you have a small increase with just the 1, 2 degrees, which is good if you have it. Because it generally means that you're in good contact and you really do a good delivery during pulses. So this is kind of reconfirmation. This is at least what I use. But for this catheter, there's no thermistors. I suspect that the three-month systematic remapping data with such a high durability of the lesion demonstrates that this catheter doesn't need it, right? I think the conformability of it is really important. I mean, I get the feeling as we play with different technologies that having contiguous contact is one of the most critical aspects, I think, of getting good lesions. That's kind of signature of what Doron produced over Sphere 9 and 360, right? Well, thank you very much for attending. Vivek, you may want to wrap it up if you think. Yeah, no, no. Thanks, everyone, for attending. I think in the United States, we're soon going to see this in a clinical IDE and hopefully soon thereafter in regular practice. So stay tuned. Enjoy HRS. Thank you.

atrial fibrillation

Pulse Field Ablation

Sphere 360 catheter

Pulmonary Vein Isolation

over-the-wire technology

clinical trials

conscious sedation

patient comfort