While similar metal mesh tubes, known as stents, are used in other arteries, it was the FDA's first approval of such a device for neck arteries.
The newly approved stent and filter combination, made by Indianapolis, Ind.-based Guidant Corporation, will aid patients with past stroke symptoms and at least 80 percent blockage of the carotid artery. The FDA approved two versions of the device systems; one can be inserted by a single doctor, the other by a pair of medical workers.
According to the American Heart Association, roughly 700,000 Americans suffer a stroke each year. Stroke is the nation's No. 3 killer and is among the leading causes of severe disability, the association says.
The FDA reviewed studies using the carotid stent in 581 patients at 45 medical centers. The patients either had past strokes or were in danger of having a future stroke. The company's studies indicated the devices cleared blocked neck arteries in 92 percent of patients.
Within 30 days of undergoing the procedure, patients were less likely to die, or suffer a stroke or heart attack than patients who had undergone surgery, the studies indicated.
An estimated 200,000 Americans undergo such surgery to clear clogged neck arteries each year. The Guidant device will be used on patients for whom surgery to remove blockage is not an appropriate option.
Guidant's system threads the stent to the neck artery by way of a catheter that is inserted into the groin. An accompanying filter opens to snag debris that might otherwise travel to the brain, causing a stroke.
Company studies of the stent's performance will continue to gauge its long-term safety and effectiveness.