Abbott has received US FDA approval for a new minimally invasive device to treat patients with carotid artery disease, a risk factor for stroke. Abbott received FDA approval for the Xact Carotid Stent and 510(k) clearance for the Emboshield Embolic Protection System to treat patients at risk of stroke who are not favourable candidates for surgery. With this, Abbott becomes the second company to enter the US carotid stent market.

The new system features a stent specifically designed to treat diseased carotid arteries - arteries in the neck that have become clogged or partially blocked due to the build-up of fatty plaque and debris (atherosclerosis). The Xact stent is self-expanding and has a closed-cell design that creates a tightly knit yet highly flexible mesh intended to help restore the inner diameter of a carotid artery, promote a smooth inner vessel surface, and potentially reduce the release of fatty debris (emboli) from a diseased vessel when it is treated, which can lead to stroke, explained a release here.

The Xact stent is designed for use in combination with the fully retractable Emboshield filter. Emboshield is designed to capture emboli that can break off during a carotid stenting procedure, and it is the only filter to feature Barewire, a proprietary technology developed to allow for better control of stent placement once the filter is in place and fully apposed against the vessel wall.

"Surgery, or carotid endarterectomy, has proven a reliable method for treating carotid artery disease, but it is not the ideal treatment for everyone," Gary S. Roubin, chairman of the department of interventional cardiology at Lenox Hill Hospital in New York said adding, "Some patients may stand to benefit more from a minimally invasive procedure with a carotid artery stent and embolic protection that avoids the risk associated with general anesthesia, eliminates the risk of cranial nerve injury and neck scarring. The Xact Carotid Stent and Emboshield Embolic Protection System provide a truly advanced minimally invasive treatment alternative for these patients."

Abbott established an exclusive agreement to market and distribute Emboshield in February 2001 with Mednova Limited in Galway, Ireland, which developed the stent and filter.