Abbott received CE mark approval for Amulet 360, its next-generation left atrial appendage occluder designed for patients with non-valvular atrial fibrillation at risk of stroke. The clearance provides a regulatory platform for Abbott to pursue share in the left atrial appendage occlusion market dominated by competing Watchman devices. For device firms, CE approval is both a commercial inflection point and a clinical pathway enabler, as it supports broader adoption within EU markets and supports reimbursement conversations tied to stroke risk management.