Introduction The Surpass Evolve Flow Diverter (FD) System is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥2.0mm and ≤5.0mm.

Aim of Study The Spanish Society of Neuroradiology (GENI) aimed to evaluate safety and efficacy of the Stryker Evolve FD up to 12 months after implant in a real world setting.

Methods GENISE is a single arm, prospective, multicenter, core-lab reviewed study. From February 2021 to June 2023, consecutive patients with an unruptured cerebral aneurysm treated with Evolve FD were enrolled in 18 spanish centers after local Ethical Committee approval.

Results 176 consecutive patients with a total amount of 222 aneurysms were included. The aneurysms were located in the anterior (91.9%) or posterior (8.1%) circulation. A total amount of 188 devices were deployed. The deployment success rate was 100%. In 60 (34.1%) cases post processing was performed to optimize device wall apposition using subsequently ballon remodelling or laser cut stent. Occlusion rates at 3-6 months were 67.8%, and at 12 months 85.4%. At 6 months morbidity and mortality were 6,8% and 1,7%, respectively and 12 cases (6.9%) demonstrated >30% in-stent stenosis.

Conclusion This study demonstrates Evolve FD device deployed in unruptured intracranial aneurysm has an overall satisfactory device performance, safety and effectiveness

Disclosure of Interest no.