The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.
Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
Age 18-80 years at screening
Patients who are suitable for non-emergency endovascular embolization of saccular IAs
IA located in the anterior or posterior circulation
Patient able to give their informed consent can be included in this study. Exclusion Criteria
Ruptured intracranial aneurysm
Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
Contraindication for arterial access