FDA Approves Abbott’s Carotid StentFDA Approves Abbott’s Carotid Stent

Abbott Vascular Devices (Redwood City, CA) received FDA approval earlier this month for its Xact carotid stent and Emboshield embolic protection system. The device is intended to treat carotid artery disease, which results in an estimated 700,000 strokes and 280,000 deaths in the United States annually.

Carotid stents are a less-invasive alternative to the surgical procedure known as carotid endarterectomy. Carotid stents are used to prevent strokes by unclogging arteries in the neck that can become partially blocked with a buildup of fatty plaque and debris, a condition known as atherosclerosis. The Xact system, similar to other products on the market or in development, consists of two devices: the carotid stent and a mesh filter system designed to capture any emboli or debris material that may become dislodged during the stenting procedure. Abbott's Xact stent and Emboshield embolic protection system were developed in cooperation with Mednova Ltd. (Galway, Ireland) and received the CE Mark for European distribution at the end of 2003.