FDA approves stroke-preventing device
The FDA approved on Tuesday two versions of a stent designed to prevent strokes. Stroke sends thousands of seniors to rehabilitation and nursing facilities each year.
The newly approved stent and filter combinations aid patients for whom more extensive surgery is not possible to clear blocked passages with their past stroke symptoms and clear blocked carotid arteries, the main blood vessel leading to the brain. One version can be inserted by a single doctor, another by a pair of medical workers. The device is made by Guidant Corporation of Indianapolis.
The FDA examined studies that showed the carotid stents cleared blocked neck arteries in 92% of the patients. In the 30 days after undergoing the insertion procedure, the patients were less likely to die or suffer a stroke or heart attack than patients who had undergone surgery. The studies used 581 patients who had recently suffered from a stroke or showed potential for a future stroke in 45 medical centers.
Stroke is the nation's No. 3 killer and a leading cause of severe disability, according to the American Heart Association. Roughly 700,000 Americans suffer a stroke each year.