Medtronic has today announced the European launch of Artisse—a new intrasaccular device designed to treat intracranial aneurysms by conforming to the shape of the aneurysm. The launch coincides with interim data that examine the safety, efficacy and performance of the device being presented for the first time at LINNC Paris 2024 (3–5 June, Paris, France).
Artisse was designed to address the needs of complex wide-neck bifurcation aneurysms that have traditionally been managed by stent-assisted coiling, coil adjunctive neck-bridging devices and other intrasaccular basket devices. The former two methods require multiple steps and multiple devices, with stent-assisted coiling requiring dual antiplatelet therapy, which can present challenges in ruptured aneurysms.
Medtronic claims that Artisse offers a simple, one-step technique in treating these complex and simpler aneurysms alike.
Artisse is highly conformable, engineered from dual layers of high-density platinum core and nitinol drawn filled tubing (DFT) wires in a flared design. This sophisticated construction allows it to flex to conform to the unique contours of most aneurysms while exerting the optimum outward radial force needed to fill the space securely, the company also states in a recent press release.
“Artisse behaves differently to other intrasaccular devices because I can control the optimal positioning of the device in the aneurysm,” said Riitta Rautio (Turku University Hospital, Turku, Finland). “Due to its conformability and softness, I can reach the optimal position of Artisse in the aneurysm with partial re-sheathing of the device and slight movement of the microcatheter.”
The device’s flexibility, smooth distal tip and gentle deployment make Artisse atraumatic—reducing risk to, and stress on, the aneurysm walls.
Early-experience analysis presented at LINNC Paris 2024, from a study involving 35 patients enrolled into the multicentre, core lab-adjudicated European INSPIRE-A registry, shows that 80% of patients treated with Artisse achieved complete occlusion by a six-month angiographic assessment, indicating successful aneurysm occlusion with no residual filling.
“Artisse is a promising device that appears to be a step in the right direction for intrasaccular technology,” said Tufail Patankar (Leeds General Infirmary, Leeds, UK). “Its softness and conformability allows you to manipulate the device within the aneurysm. Complex wide-neck angled aneurysms that were previously difficult to treat with other intrasaccular devices now seem to be treatable with Artisse.”
According to Medtronic, Artisse is simple to use and faster when compared with coils, or balloon- or stent-assisted coiling. In deployment, the device opens gradually and smoothly with a ‘flowering mechanism’, with no kick-back, so that it feels like pushing a coil. The device also features a handheld electrolytic detachment system that provides immediate confirmation, instant audio and visual feedback upon detachment, and complete radiopacity.
Medtronic offers expert clinical support, including access to simulation software, further supporting sizing selection with Artisse, the recent release notes.
“At this time, I experience very satisfying results for both unruptured and ruptured aneurysms treated with the Artisse device,” said Cyril Dargazanli (University Hospital of Montpellier, Montpellier, France).
“Combined with simulation and the radial approach, Artisse is redefining the standard of care of unruptured aneurysms, offering each patient a safe and customised solution, reinforcing the perspective of aneurysm screening in populations at risk to finally achieve the ultimate goal of our community: reducing subarachnoid haemorrhage worldwide,” added Vincent Costalat (University Hospital of Montpellier, Montpellier, France).
