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In light of the official European launch of the Artisse aneurysm embolisation system (Medtronic) at LINNC Paris 2024 (3–5 June, Paris, France), NeuroNews speaks to three of the device’s earliest users—Monika Killer-Oberpfalzer (Salzburg University Hospital, Salzburg, Austria), Markus Möhlenbruch (Heidelberg University Hospital, Heidelberg, Germany) and Vincent Costalat (University Hospital of Montpellier, Montpellier, France)—to discuss their experiences to date, and find out how Artisse differs from other intrasaccular technologies.
“When I first saw it, I thought, ‘wow, this is exactly what we need!’”, Killer-Oberpfalzer recalls. “It combines the things that are already on the market, in a better way compared to what was available before.”
Artisse—a reconfigured and enhanced update to the previous Luna aneurysm embolisation system—is a self-expanding, braided, ovoid implant made from a double layer of nitinol wire mesh. While this description alone may not sound drastically different to those of prior-generation intrasacculars like the Woven EndoBridge (WEB; Microvention/Terumo) or Contour (Cerus Endovascular/Stryker), Killer-Oberpfalzer believes Artisse features many of the benefits of these more established technologies while also carrying a few even more unique advantages of its own.
She notes that, during treatments she has performed with Artisse, the device has displayed an ability to be positioned at the neck of the aneurysm both effectively and easily—meaning it does not “compromise” the parent artery—and can also “remodel” itself in order to truly conform to the shape of the aneurysm in question.
“That is a real advantage,” Killer-Oberpfalzer continues. “And, another advantage—my favourite— is the softness of Artisse. Usually, when you push an intrasaccular device into an aneurysm, your microcatheter gets pushed back and you may lose your position in the aneurysm, but that doesn’t happen with Artisse because it’s so soft. The microcatheter almost doesn’t move at all. It is very stable and easy to handle, and that makes it much easier to position the device.
“I always say that a monkey should be able to use the device. The easier the device is to use, the easier and shorter the procedure is, and the less likely you are to have complications. If a device gives you a better chance of not having complications, I think it is the next step and the next generation of device that should be used, and that’s why I’m really happy to have it available at the moment.”
While it remains unlikely that we will see a non-human primate in the angio suite any time soon, even with the latest technological advancements, Killer-Oberpfalzer believes the “self-explanatory, user-friendly” nature of Artisse means it should be relatively straightforward for less experienced clinicians and other first-time users to train with the device. Many of the outstanding benefits of Artisse that Killer-Oberpfalzer alludes to here—conformability, softness and overall ease of use—among others, are also endorsed by her peers.
“The ease of use of this new device is very high,” Möhlenbruch comments. “I don’t think it’s a big deal whether or not you are an experienced neurointerventionist. If you know how to use other intrasaccular devices then, after you have seen one or two [Artisse] cases, you can easily use this device in a safe way. You can also use any 021 microcatheter you want with Artisse. There’s no need to use a specific microcatheter so, if you are more familiar with ‘microcatheter A’, you can use it; if you prefer ‘microcatheter B’ at a different centre, then you can also use it, which I think is a nice advantage.”
“In comparison to the WEB, which was the benchmark for us, we found the device to be extremely soft and ‘non-aggressive’—especially at the dome of the aneurysm,” Costalat adds. “The WEB tends to be very stiff before becoming soft again, whereas Artisse is soft immediately after starting the delivery. So, in this aspect, we have found the device to be extremely safe to use, particularly at the first step of deployment. The other thing we found to be extremely interesting was its ability to remodel and modify its shape according to the aneurysm. And, sometimes, you will fill part of the aneurysm that you may not expect to fill, because of its softness. It is surprisingly good in this sense. The ease of use is extremely high too, and I think it offers a great simplification of complex situations.”
Early experiences
All three physicians relay similar stories in terms of their usage of the Artisse device to date. Killer-Oberpfalzer and her colleagues in Salzburg began using it in the final months of 2023 and have completed a total of 17 cases with it thus far, at time of writing in early May 2024. She reports having treated ruptured and unruptured aneurysms alike to date, and almost “everything that is available” in terms of aneurysm locations: most commonly in the middle cerebral artery (MCA), but also the anterior and posterior communicating arteries (AComA/PComA), basilar artery, carotid artery, and posterior inferior cerebellar artery (PICA).
“The first case was a very difficult one,” she says. “I selected the aneurysm very carefully: a nice, small basilar tip. But, the access to the aneurysm was so difficult. It was the first case, so the whole team was there, and I said, ‘If this device pushes my microcatheter out of this aneurysm, I’ll coil it’. But then it was so easy—as I said before, [the microcatheter] did not move—it was unbelievable. Since then, in whatever case we’ve done, it’s astonishing how similar it is. It just, simply, works.”
Killer-Oberpfalzer goes on to state that her experience has seen “one small problem” relating to detachment of the device and, in light of this, advises prospective users of the importance of cleaning the delivery system carefully before the procedure. In addition, she says she is yet to experience any difficulties relating to the actual positioning of the Artisse device, leading to it becoming her go-to intrasaccular tool of choice.
“You always expect that something has to go wrong because, after a few cases, there’s always something that happens—there’s no perfect device in the world,” she comments. “But, so far, either I’ve been really lucky or, I think, it’s easier to use than the other intrasacculars that are available. All of my Artisse cases have been perfect, from the first one onwards.”
Möhlenbruch recounts that he and his colleagues in Heidelburg performed one of the first Artisse cases anywhere in Europe, which took place towards the end of 2022. This and every subsequent treatment at their centre have been completed as part of the INSPIRE-A registry—a real-world, postmarket database set up to evaluate the safety and efficacy of Medtronic’s various aneurysm therapies across Europe. And, similarly to Killer-Oberpfalzer, Möhlenbruch says they have treated “almost all” bifurcation aneurysms, with locations mainly consisting of the MCA, AComA, and basilar artery tip.
“We were one of the first centres using the Artisse device, and we are still one of the centres performing the largest number of treatments,” he notes. “We have treated close to 20 patients [as of early May 2024]—I have performed about two thirds of those cases—and we are very happy with the device.”
In addition, having initially had the opportunity to “play” with the device during its development phase, via in-silico testing, Costalat and his team in Montpellier began performing clinical cases with Artisse in the second half of 2023. Their centre has since used the device in a total of 30 cases, predominantly involving wide-neck bifurcation aneurysms in the MCA and anterior cerebral artery (ACA), but also some in carotid and basilar-tip locations as well.
Costalat, like Killer-Oberpfalzer and Möhlenbruch, further states he has seen the Artisse device used mainly in unruptured cases, as well as a smaller number of ruptured ones, with a consistent safety profile being observed across both.
“We have some six-month follow-up data coming, and almost for one year as well, and the follow-up up to now is pretty encouraging, showing no aneurysm recurrence at the moment,” Costalat says. “But, of course, we need mid-term and long-term follow-up to ensure that Artisse will be stable over time.”
Killer-Oberpfalzer corroborates these views, noting that six-month follow-up data from a total of roughly 50 patients are available to date, and the device has demonstrated a good safety profile therein.
“We need to have more data than that—I believe the device could be ‘less dangerous’ [meaning it may produce fewer complications], but that’s just my impression,” she continues. “We need to prove it, and we need long-term follow-up in terms of clinical outcomes and recanalisation rates. It is very early, but what we have seen so far is very promising.”
Here, Möhlenbruch claims that the Artisse device is especially well-suited to certain patient anatomies; specifically, aneurysms found in more vertical, ‘Y-shaped’ bifurcations.
“The proximal part of Artisse is also shaped like a ‘V’, and this may have some flow-diverting impact at the level of the bifurcation—which may also lead to a lower rate of recurrence of the aneurysm over time,” he adds. “We do not know this for sure at this time, but this is hopefully what we’ll see when we look to the one- and two-year follow-up data.”
Möhlenbruch goes on to highlight multiple positive characteristics of Artisse: “The overall friction when you introduce the Artisse device into the microcatheter is actually very low—the force you need in order to be able to push the system to the location you want is very low. This makes the whole procedure very safe, because it gives you much more control.
“Another thing is the visibility, which is always very important for us, as we like to see what we’re doing and how the devices act in the aneurysm. And, from my point of view, the visibility of the Artisse device is highly sufficient. You see when the device starts to open, you see when the device is completely open, and this also adds more safety to the whole procedure.
“The last point where I also see benefits is with the detachment system. You have a proximal marker located on the device, and the marker on the delivery wire, and—immediately after detachment—you see that there is a greater distance between these two markers, and you know that the device is detached. Again, this contributes to even greater procedural safety. In all but one of our cases, it has been very easy to detach, and there was no movement afterwards either. This is also important because you will ideally have the same device morphology before and after you detach it. There is no change in the morphology of the Artisse device when you retrieve the delivery wire.
“From my personal experience, this is the best detachment system when we speak about intrasaccular devices. It’s very reliable—it takes a little longer, but then it is reliable.”
Simulating for success
Once again, there is broad agreement between the three physicians over what the main limitation—and probably the only current limitation—of the Artisse system is. Killer-Oberpfalzer reports that only aneurysms up to a certain size, between 3mm and 6.5mm in diameter, can be treated using the device configurations that are currently available. Costalat agrees that concerns around sizing constitute the only real limitation of Artisse in its current form, as it cannot yet be used for very small aneurysms and its profile of delivery is still limited to 021 microcatheters.
In addition, when it comes to choosing the right device size for a given aneurysm, there is consensus between Killer-Oberpfalzer and Möhlenbruch on the importance of ‘oversizing’ slightly, in order to fill the aneurysm completely. If unsure between two different sizes, Möhlenbruch’s advice would be to go for the larger of the two options, in order to ensure that the aneurysm can be completely filled. He attributes this to the softness and the ability of the device to configure, even to an irregular aneurysm morphology, “very well”.
However, both feel that these decisions are relatively simple and, in the words of the former, are made “even easier” by the artificial intelligence (AI)-powered preoperative planning tool Sim&Size (Sim&Cure), which Medtronic makes available to all Artisse users. Killer-Oberpfalzer also avers that combining the customary sizing chart provided by Medtronic with this simulation technology gives the operator “a really good selection base”.
“What we’ve found extremely valuable is the utilisation of the device with simulation assistance, as the simulation helps us to understand the final deployment of the device into the aneurysm sac as well as the level of compression of the device against the wall of the aneurysm,” Costalat contributes. “I would advise using the simulation software to size the device, because only simulation can show you the wall apposition. We have learned that this is a very important risk factor for aneurysm recurrence—if the device is not apposed to the wall, or if you do not reach a certain level of compression. You should use simulation assistance, because you want to reduce the chance of making a mistake and you will add safety to the procedure.”
Wider implications and a positive outlook
Touching on the more general upsides of newer intrasaccular aneurysm treatments, Killer-Oberpfalzer says that ‘one-and-done’ devices like Artisse lead to shorter, smoother procedures that are often completed after one deployment—whereas coiling can take two hours or more, and may require the placement of several coils consecutively. She also relays that she has not needed to supplement any of her Artisse treatments to date with a stent. And, as is the case with other intrasacculars, Killer-Oberpfalzer highlights the avoidance of dual antiplatelet therapy (DAPT)—a requirement when treating intracranial aneurysms using a flow diverter—as another “big advantage” carried by Artisse.
“Comparing it to coiling—which is also an intrasaccular treatment—we know that coils recanalise, especially in wide-neck aneurysms,” she adds. “Here, with Artisse, we have an intrasaccular device that acts like a flow diverter. Its stability, once [the aneurysm] is occluded, should be the same as with a flow diverter. So, less recanalisation, less medication, easier to use, shorter procedure times—there’s nothing more that we can really ask for!”
Möhlenbruch also weighs in on this point, stating: “The goal of an intrasaccular device is to avoid using a stent or flow diverter in the parent artery, and, here, the major benefit of using an intrasaccular device is that we can reduce or avoid antiplatelet therapies, so that there is no additional risk created by the medication you have to give to the patient. The risk is low but, if you give DAPT to the patient, you do add some risk. And the beauty of intrasaccular devices like Artisse is that there’s no need to do this. Therefore, from my point of view, if we’re able to show that we can achieve stable results with Artisse, then I think it’s the future of treatment—the perfect treatment—for aneurysms that fit to the size of the device.”
“At the moment, I think it’s the best and the easiest to use but, if you’d asked me a year ago, I would’ve said Contour is the only one,” Killer-Oberpfalzer says next. “There are always new things coming, and I’m pretty sure [Medtronic] will also develop Artisse further and that they already have ideas for how to make it even better. With further development and good ideas, it has a real future.”
“The first and most important point at the moment is that we can already prove that the device is very safe,” Möhlenbruch adds. “This is what we have seen from the INSPIRE registry’s safety data analysis—the rate of complications, periprocedural and postprocedural, is super low. So, it’s a safe device. The second question: is it effective? This is something we do not know for certain at the moment, because we are still following the patients. For this question, I would like to see one-year follow-up data from a GCP [good clinical practice] trial—like INSPIRE—and we are looking forward to these data right now.”
“Improving the safety profile of neurovascular interventions—for example, with Artisse—will push us in the direction of global screening for populations at risk of carrying aneurysms, and treating them in a systematic fashion, with very low risks,” Costalat concludes. “So, the growing generation of new intrasaccular devices may help us to reach the point where the preventive treatment of aneurysms will be far safer and can be offered at a large scale.”
DISCLAIMER: The data and content included in this article express only the clinical perspectives of the interviewees. They are completely independent and do not necessarily reflect the opinions of Medtronic.
