Introduction Artisse, a novel intrasaccular device, is a reengineered version of the previous device and 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 First In Human (FIH) experience with Artisse.
Methods Patients with wide-neck bifurcation aneurysms (WNBAs) were enrolled in a Limited Market Release under Medtronic’s Innovative Neurovascular Product Surveillance Registry (INSPIRE) and treated per standard of care. INSPIRE-A is designed to continuously monitor 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 14 patients have already been included in the FIH experience with focus on the procedural and early safety outcomes. The locations of the IAs were MCA, PComA, BA, AComA, and ICA. The maximum IA diameter ranged from 3.8–7.1 mm. Till date no device-related adverse events (0%, 0/14) have been reported. At the ESMINT Congress, updated data on safety and early outcomes will be presented for all available patients.
Conclusion Based on the current FIH experience data, the Artisse device demonstrates procedural and early safety for the treatment of WNBAs.
Disclosure of Interest MM and SL have nothing to disclose. RR is consultant for Microvention, Stryker and Medtronic. JF reports grants and personal fees from Anandis, Cerenovus, Microvention, Medtronic, Stryker, and personal fees from Phenox and Penumbra. JF also serves as the CEO of Eppdata. LS reports grants or contracts from Philips; consulting fees from Balt, Medtronic, Phenox, Microvention, Stryker; payment/honoraria from Balt, Medtronic, Microvention, Stryker; support for attending meetings and/or travel from Balt, Medtronic, Microvention, Stryker.
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