The Food and Drug Administration has approved a carotid stent from Abbott Laboratories that's designed to be a minimally invasive treatment for patients with carotid artery disease.
The FDA issued premarket approval to Abbott's Xact carotid stent, and issued 510(k) clearance for the Abbott Park, IL, company's Emboshield embolic protection system. Emboshield is designed to capture emboli that can break off during a carotid stenting procedure, thus preventing a stroke.
Xact and Emboshield are designed to be used for patients who aren't good candidates for carotid endarterectomy. Emboshield and Xact already have CE Mark approval, and were launched in the European Union at the end of 2003, according to Abbott.
By AuntMinnie.com staff writers
September 16, 2005
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