Filter reduces stroke incidence in carotid stenting
Designed to incorporate the three requirements for successful and safe carotid stenting, namely low device profile, optimal filtration and ease of use, the FiberNet embolic protection system (EPS) from Lumen Biomedical provides the optimal balance between sufficient filtration on the one hand and the maintenance of safe perfusion on the other. Using a highly effective filter made of a 3-dimensional matrix of fibres, the FiberNet EPS system captures any particles released during the carotid artery stenting procedure and thus prevents microscopic debris from travelling to the brain. After the particles have been captured, the FiberNet filter is then retrieved into the retrieval catheter and removed from the patient.Recently the results of a multi-centre, single-arm clinical trial designed to evaluate the performance of the new system have been presented. The trial evaluated the FiberNet EPS during the carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. The mean age of the patients participating in the clinical trial was 74 years (21% were octagenarians), 64% were male and 20% were symptomatic. Overall, the combined major adverse event rate at 30 days for all deaths, stroke and myocardial infarction (MI) was 3.0%. There were five strokes (four ischaemic and one haemorrhagic), a 30 day stroke rate of 2.1%. There were no unanticipated adverse device effects. The results demonstrate that the new system’s unique features can contribute to a lower stroke rate during carotid artery stenting in high surgical risk patients.
Lumen Biomedical, Inc
