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).