Study Ended Due To Failed Brain Stents

The National Institute of Neurological Disorders and Stroke reported that at least 55,000 of the 795,000 annually occurring strokes are due to blockages in small arteries in the brain. In August 2005, the FDA approved Boston Scientific a registry study that consisted of 45 high-risk patients who had already failed medical treatment to receive a brain stent that was intended to prevent fatal and disabling strokes. The stent resembled those used to open vessels leading to the heart. The study resulted in positive results, showing only a 4.4% stroke rate in the first month. Then, the FDA approved the device further and thousands of patients received the stent that propped open blocked arteries in the brain, even though there was still not solid evidence to support this belief because the registry study had not had a control group and typically registry studies show better results than studies with a comparison group. Recent results showed that the stent more than doubled the occurrence of strokes and patients who received the device had a much higher likelihood of having strokes than the control group. The study was ended because it was doing much more harm than benefit and now much more attention has been drawn to the strictness of the FDA with brain stents.

Sources:

http://www.theledger.com/article/20110908/NEWS/110909501?p=1&tc=pg

http://www.nytimes.com/2011/09/08/health/research/08stent.html