Making Unique Observations in a Very Cluttered World

Thursday, 8 September 2011

Study Is Ended as a Stent Fails to Stop Strokes -

Study Is Ended as a Stent Fails to Stop Strokes - 

The Food and Drug Administration approved the device six yearsago 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 strokeor death raised serious questions about whether the F.D.A.’s procedures for approving such a medical device ended up putting patients at risk.
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 pressurecholesterol and diabetes, that the study was abruptly terminated.
The study comes just a month after an expert panel at the Institute of Medicine, a major scientific group, recommended that the F.D.A. replace its more usual regulatory system for devices because it failed to establish the safety and efficacy of less risky devices, like artificial hips, before licensing.
While neurologists were deeply disappointed by the study’s outcome, they also said it was better to find out that the treatment was, on balance, harmful before it became standard medical practice.

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