updated 8/30/2004 10:38:57 AM ET 2004-08-30T14:38:57

The Food and Drug Administration has approved the first device to remove blood clots from the brains of people suffering strokes, the device manufacturer said on Monday.

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In 80 percent of strokes, a blood vessel in the brain becomes clogged by a blood clot, increasing the chance of severe disability or death.

The Merci Retriever, a tiny corkscrew threaded through an artery to remove the clot and restore blood flow, is produced by Mountain View, Calif.-based Concentric Medical.

The device was tested at 25 medical centers around the nation in 141 patients ineligible for a drug that clears clots but must be used within three hours of suffering a stroke.

A 'major limitation'
Dr. Larry Goldstein, director of Duke University’s Center for Cerebrovascular Disease, called the approval “interesting” but added that it remains unclear how many patients would benefit from the new treatment option.

As part of the patient assessment, a catheter must be inserted through the groin and snaked up the artery for descriptive dye to outline blood vessels and point to obstruction, Goldstein said. The task requires skilled medical workers.

It’s not the kind of thing that is capable of being done in any hospital anywhere,” Goldstein said. “The patient has to have a clot that is not only visible, but accessible. That is a major, major limitation to begin with.”

According to the American Stroke Association, strokes are the third-leading cause of death among Americans. An estimated 700,000 people suffer strokes each year; some 163,538 died in 2001, the most recent annual data available.

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