The U.S. Food and Drug Administration said Wednesday it has limited the use of a Stryker Corp. brain stent used to open narrowed arteries in some patients who have had repeated strokes.
The company's Wingspan Stent System was approved in 2005 to treat patients who have 50 percent or greater narrowing in arteries in the brain and had not improved with drug treatment. The narrowing of such arteries is caused by the buildup of plaque, which in turn can cause strokes from the reduced blood flow to the brain.
The product is designed to reopen narrowed arteries to potentially prevent additional strokes.
However, the FDA said clinical data have shown that the stent may increase the risk of strokes and heart attacks in some patients.
The agency narrowed the use of the Wingspan stent system to patients ages 22 to 80 years old who have a narrowing of the arteries of 70 percent to 99 percent, have had at least two previous strokes and were considered to have made a good recovery from those strokes. Patients' most recent stroke also should have occurred more than seven days prior to planned treatment with Wingspan, the FDA said. Stryker didn't immediately return a request for comment, but the company has previously said it would cooperate with the agency.
In March the matter was brought to an FDA advisory panel for discussion. While the panel said clinical data were lacking showing patients benefited from the device, some panel members said it might be appropriate for a small segment of patients.