Javelin Medical Ltd

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.