Study Is Ended as a Stent Fails to Stop Strokes

A promising but expensive device to prop open blocked arteries in the brain in the hope of preventing disabling or fatal strokes failed in a rigorous study, researchers reported on Wednesday. Those who got the device actually had so many more strokes than those assigned to control risk factors, like blood pressure, cholesterol and diabetes, that the study was abruptly terminated.



The Food and Drug Administration approved the device six years ago on the basis of a humanitarian exemption, which did not require solid evidence that it would prevent strokes. Thousands of patients got the devices since then, according to the study’s lead researcher. The finding that the devices actually more than doubled the rate of stroke or death raised serious questions about whether the F.D.A.’s procedures for approving such a medical device ended up putting patients at risk.

http://nyti.ms/nbcYEC