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FDA Expands Approved Use For Carotid Stent
Date:5/6/2011

arction) as those who underwent surgery.

An outside expert advisory panel convened by the FDA on Jan. 26, 2011, found the RX Acculink to be generally safe and effective for use in this new group of patients. But the panel emphasized the need for additional long-term follow-up information and the importance of the stent's use in conjunction with an embolic protection device to capture plaque and other debris that break away during the procedure, potentially causing a stroke.

As a condition of the approval, the manufacturer, Abbott Vascular, is required to conduct a post-approval study, which will follow new patients treated with RX Acculink for at least three years to confirm the results identified in the pre-market study. The post-approval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by the physician's experience with the product, and whether patients who show symptoms of having a clogged carotid artery experience a different outcome than those who don't show any symptoms prior to treatment. The study is consistent with recommendations made by the expert advisory panel.

Abbott Vascular, a subsidiary of Abbott Laboratories, is located in Santa Clara, Calif.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

NIH: Carotid Endarterectomy (Carotid artery surgery)

http://www.nhlbi.nih.gov/health/dci/Diseases/carend/carend_what.html

The FDA, an agency within the U.S. Department of Health an
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SOURCE U.S. Food and Drug Administration
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