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Media Contact: Sherry Baker 01 September 2004    
  (404) 377-1398   Print  | Email ]

Emory a National Training Center for New FDA-Approved Stenting Procedure
The U.S. Food and Drug Administration (FDA) has announced approval of a new technique for treating potentially life-threatening blockages in the arteries of the neck that lead to the brain. The carotid stenting procedure offers a minimally invasive alternative to carotid endarterectomy (surgical removal of arterial plaque) in patients with carotid artery disease who are at risk for stroke. The FDA has recommended that physicians who use the carotid stenting device undergo special training. The Emory Heart Center is one of thirty training sites for carotid stenting across the nation.

Just as stents (tiny mesh tubes) are often used following coronary angioplasty (a minimally invasive procedure that uses a balloon-tipped catheter to enlarge a narrowing caused by atherosclerosis to keep arteries open), they can also be used to prop open carotid arteries in the neck. The FDA's approval of the Guidant RX ACCULINK Carotid Stent system and RX ACCUNET Embolic Protection System (a tiny filter to catch clots stirred up by the procedure before they float to the brain) will allow patients with blocked carotid arteries who have been unable to undergo the rigors of surgery due to lung disease, heart disease or other illnesses to receive treatment.

"Carotid stenting is a very exciting new technology which certainly offers high-risk patients a less invasive option to carotid endarterectomy. This procedure also has significantly fewer bad outcomes (heart attack, stroke and death) when compared to carotid endarterectomy," says Emory Heart Center cardiologist Christopher Cates, MD, Director of Vascular Intervention at Emory University Hospital and Emory Crawford Long Hospital. "This is also the first catheter-based technology to show a major benefit versus a surgical procedure."

The Society for Cardiovascular Angiography and Interventions (SCAI) predicts demand for the carotid stenting procedure will mushroom following FDA approval and the SCAI is working with industry partners to help develop training programs on virtual reality simulators to train physicians. Dr. Cates and Anthony Gallagher, PhD, Emory University School of Medicine associate professor of surgery (research) and research director of the Emory Endosurgery Unit, have designed one of the first of these programs to train physicians in carotid stenting. Using simulators that look like human mannequins, physicians thread a catheter through an artificial circulatory system and view angiograms of the "patient."

"For the first time, physicians are able to practice on simulators, much like airline pilots who learn to fly first using a simulator, prior to performing carotid artery stenting on patients. Doctors learn on a simulator until they are proficient, working in life-like settings," says Christopher Cates, MD, of Emory School of Medicine and Chair of the SCAI's Board of Governors. Emory has already trained over 103 physicians using the simulator.

According to Dr. Cates, stents placed in carotid arteries following angioplasty can reduce the risk of stroke in many people. Carotid artery disease -- a buildup of atherosclerotic plaque (fatty material) in major vessels of the neck that supply blood to the brain -- is an important risk factor for stroke. Stroke is the nation's third leading cause of death and a major cause of serious, long-term disability. According to the American Stroke Association, someone in America has a stroke every 45 seconds. In all about 700,000 Americans suffer from stroke each year.

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