FDA OK’s dangerous brain stent

The U.S. Food and Drug Administration announced a decision to maintain its approval for the Wingspan brain stent system, even though it ignores a National Institutes of Health-funded study which showed that for every 11 patients treated with the Wingspan system, one additional patient dies or suffers a stroke within 30 days. Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, said the FDA decision “is further evidence that the agency is not making decisions in an evidence-based manner but, rather, stating that it believes the device will be beneficial despite evidence to the contrary.”