FDA Advisory Panel Votes 7-3 to Expand Indications for Carotid Stent

Acculink Carotid Stent expanded (top) and on balloon (bottom)

January 26, 2011 -- Gaithersburg, Maryland -- The FDA Circulatory System Devices Panel today voted 7-3 in favor of expanding the indications for carotid artery stenting, specifically for the Abbott Vascular RX Acculink Carotid Stent System. If the FDA follows its panel's recommendation, which it usually does, the approved indications for carotid stenting could now include those patients who are at "standard surgical risk" for the open surgical procedure, called carotid endarterectomy. Currently, carotid artery stenting is approved only for those patients who are higher risk for surgery.

This decision was based partially on the results from the CREST trial in which the outcomes of patients who had carotid stents were compared to those who had the surgical procedure. Although there were concerns over the slightly increased incidence of stroke seen in the stent cohort, the FDA panel felt that carotid stenting was a promising alternative to surgery for many patients.

Abbott Vascular is the company that petitioned the FDA for wider stenting indications and, according to Reuters: "Abbott's Chief Medical Officer, Dr. Charles Simonton, stated that that the stent had 'comparable outcomes' to more invasive surgery and worked for about as long to keep arteries clear. Abbott also proposed continuing to study the less risky patients if FDA allows wider use."

Charles Simonton, MD

There are currently four companies in the United States with approved carotid stents: Abbott Vascular, Boston Scientific, Johnson & Johnson, and Ev3 Inc. The U.S. market for carotid stents is currently around $70 million and a positive decision from the FDA might increase that by up to 50%.

Reported by Burt Cohen, January 26, 2011

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