TUESDAY, Aug. 31, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration has approved Guidant Corp.'s Rx Acculink carotid stent system, which is designed to keep the main artery that pumps blood to the brain from becoming clogged, reducing the risk of stroke.
The first-of-its-kind device was approved for people who have symptoms of impending stroke or whose carotid artery is at least 80 percent clogged, but who aren't candidates for more invasive surgery.
Stents, which are hollow metal mesh tubes, are designed to prop open blood vessels and keep them from becoming clogged. The devices have been used for years in heart arteries.
The system is to be inserted during angioplasty, in which a balloon-like device is used to clear a clogged artery. The stent's effectiveness was studied among 581 patients at 45 U.S. medical centers who had either experienced a stroke or were in danger of having one, the FDA said in a statement. The device was found to be 92 percent effective in keeping the once-blocked carotid artery open.
As a condition of approval, the agency said it is requiring Guidant to conduct additional studies on the stent's long-term effectiveness.
More information
For more about stroke, visit the National Library of Medicine.
