TY - JOUR
T1 - New Artisse intrasaccular device for intracranial aneurysm treatment
T2 - short term clinical and angiographic result from the prospective registry INSPIRE-A
AU - Hohenstatt, Sophia
AU - Costalat, Vincent
AU - Dargazanli, Cyril
AU - Killer-Oberpfalzer, Monika
AU - Schreiber, Barbara
AU - Rautio, Riitta
AU - Sinisalo, Matias
AU - Lamin, Saleh
AU - Chew, Han Seng
AU - Spelle, Laurent
AU - Tomasello, Alejandro
AU - Patankar, Tufail
AU - Piano, Mariangela
AU - Fiehler, Jens
AU - Möhlenbruch, Markus A
N1 - Killer: Neurology/Research Institute of Neurointervention, Paracelsus Medical University, Salzburg, Austria; Schreiber: Department of Anaesthesiology and Intensive Care, Paracelsus Medical University, Salzburg, Austria
PY - 2025/1/29
Y1 - 2025/1/29
N2 - BACKGROUND: Intrasaccular devices have broadened treatment options for wide necked aneurysms. This study presents the preliminary experience with the Artisse 2.0 device.METHODS: Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE) is a non-randomized, multicenter, real world clinical study with treatment arms for aneurysms (INSPIRE-A) and acute ischemic stroke (INSPIRE-S). This interim analysis included 87 patients enrolled from November 2022 to April 2024 in the INSPIRE-A Artisse cohort across 16 Europoean centers. Procedures followed standard clinical care, with 6 months of follow-up. Safety and efficacy endpoints included major stroke, neurological death, serious adverse events (SAEs), aneurysm occlusion, and retreatment rates. An independent core laboratory assessed imaging, and all SAEs were reviewed by a clinical events committee. The Artisse steering committee provided independent oversight of the data.RESULTS: The Artisse device achieved an overall successful implantation rate of 96.6% (84/87), with satisfactory placement rates of 98.7% (74/75) for unruptured and 88.9% (8/9) for ruptured aneurysms. Following the procedure, 46.2% of unruptured aneurysm patients were receiving antiplatelet therapy (APT), predominantly aspirin monotherapy, while no ruptured aneurysm patients received APT. Device related SAE rate was 1.3% (1/87), and the overall stroke rate was 2.3% (2/87), including both ruptured and unruptured aneurysms. At 6 months, 80.0% (28/35) of patients with unruptured aneurysms showed complete obliteration, with no recurrences or retreatments.CONCLUSIONS: Preliminary experience with the Artisse 2.0 device demonstrated high technical success, favorable safety, and efficacy in aneurysm obliteration at 6 months. Larger studies with longer follow-up periods are needed to confirm these findings.
AB - BACKGROUND: Intrasaccular devices have broadened treatment options for wide necked aneurysms. This study presents the preliminary experience with the Artisse 2.0 device.METHODS: Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE) is a non-randomized, multicenter, real world clinical study with treatment arms for aneurysms (INSPIRE-A) and acute ischemic stroke (INSPIRE-S). This interim analysis included 87 patients enrolled from November 2022 to April 2024 in the INSPIRE-A Artisse cohort across 16 Europoean centers. Procedures followed standard clinical care, with 6 months of follow-up. Safety and efficacy endpoints included major stroke, neurological death, serious adverse events (SAEs), aneurysm occlusion, and retreatment rates. An independent core laboratory assessed imaging, and all SAEs were reviewed by a clinical events committee. The Artisse steering committee provided independent oversight of the data.RESULTS: The Artisse device achieved an overall successful implantation rate of 96.6% (84/87), with satisfactory placement rates of 98.7% (74/75) for unruptured and 88.9% (8/9) for ruptured aneurysms. Following the procedure, 46.2% of unruptured aneurysm patients were receiving antiplatelet therapy (APT), predominantly aspirin monotherapy, while no ruptured aneurysm patients received APT. Device related SAE rate was 1.3% (1/87), and the overall stroke rate was 2.3% (2/87), including both ruptured and unruptured aneurysms. At 6 months, 80.0% (28/35) of patients with unruptured aneurysms showed complete obliteration, with no recurrences or retreatments.CONCLUSIONS: Preliminary experience with the Artisse 2.0 device demonstrated high technical success, favorable safety, and efficacy in aneurysm obliteration at 6 months. Larger studies with longer follow-up periods are needed to confirm these findings.
U2 - 10.1136/jnis-2024-022576
DO - 10.1136/jnis-2024-022576
M3 - Original Article
C2 - 39880621
SN - 1759-8478
JO - JOURNAL OF NEUROINTERVENTIONAL SURGERY
JF - JOURNAL OF NEUROINTERVENTIONAL SURGERY
ER -