Treatment for Carotid Artery Disease

The system has been cleared by the U.S. Food and Drug Administration (FDA) for treating patients at risk of stroke who are not good candidates for surgery.

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 reduce the release of fatty debris, or emboli, from a diseased vessel. The stent is used in combination with the retractable Emboshield filter, designed to capture emboli that can break off during a carotid stenting procedure. It is the only filter to feature Bareware, a proprietary technology that allows for better control of stent placement once the filter is in place and fully apposed against the vessel wall. Both the Xact stent and the Emboshield have received the CE Mark.

The stent and filter were developed by Mednova Limited (Galway, Ireland). Under an agreement with Mednova, Abbott Laboratories (Abbott Park, IL, USA) has exclusive rights to market and distribute the Emboshield. In the first multi-center, randomized trial, Abbott Vascular (Redwood City, CA, USA) is investigating the benefits of carotid artery stenting in the broader asymptomatic patient population: patients without symptoms of stroke who have carotid artery disease and who would otherwise be referred for surgery. People with more than 70% stenosis of the carotid artery have an elevated risk of stroke. Abbott is conducting the trial with its Xact stent and Emboshield.

"Surgery, or carotid endarterectomy, has proven a reliable method for treating carotid artery disease, but it is not the ideal treatment for everyone,” said Gary S. Roubin, Ph.D., M.D., chairman of the department of interventional cardiology at Lenox Hill Hospital in New York City (NY, USA). "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 and eliminates the risk of cranial nerve injury and neck scarring.”




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