Lumen Biomedical FiberNet
This article was originally published in The Gray Sheet
Executive SummaryEmbolic protection system for carotid artery stenting will debut in the first quarter of 2009 following receipt of 510(k) clearance, announced Nov. 19. Clearance of the device, which captures debris released during stenting, was based on the multi-center EPIC trial of 237 high-surgical-risk patients with a critical carotid artery stenosis. The study showed a major adverse event rate of 3% at 30 days and no unanticipated adverse device effects. FiberNet's 30-day stroke rate of 2.1% is the lowest of any filter available in the U.S., Lumen claims
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