Article Text
Abstract
Introduction Artisse has several advantages: An atraumatic distal tip that protects the intracranial aneurysm (IA) dome during deployment, proximal and distal marker bands offer enhanced device visibility for ease of use, a dual-layer mesh basket provides a balance of radial force and conformability for a secure fit and a flared shape helps the device appose against the IA wall and cover the neck.
Aim of Study Update on the clinical experience with Artisse.
Methods Patients with wide-neck bifurcation aneurysms (WNBAs) were enrolled in Medtronic’s Innovative Neurovascular Product Surveillance Registry (INSPIRE) and treated per standard of care. INSPIRE-A continuously monitors the safety and performance of newly commercialized Medtronic devices for the treatment of IAs. Site data are monitored, safety data are assessed by an independent clinical events committee, and angiographic data are assessed by an independent core laboratory.
Results 60 patients have been included in the clinical experience. The IAs locations were MCA, ACA, BA, AComA, and ICA. The aneurysm dome widths ranged from 2.1-7 mm. Till date, in patients implanted with Artisse, no serious or symptomatic device-related adverse events (0%, 0/60) have been reported, as adjudicated by CEC. At 6-month imaging follow-up, complete aneurysm obliteration (RROC Class I) was reported in 76.2% (16/21) of patients. At the ESMINT Congress, updated data on safety and early outcomes will be presented for all available patients.
Conclusion Based on the updated clinical data, the Artisse device demonstrates procedural and early safety and promising results for effectiveness for the treatment of WNBAs.
Disclosure of Interest no.