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FDA Approves New Device to Treat Brain Aneurysms
Date:4/6/2011

SILVER SPRING, Md., April 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.

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An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women.  

The size of an aneurysm can vary from small (less than .25 inches) to giant (larger than 1.25 inches). Its shape may also vary; for example, it may be balloon-like with a narrow neck extending from the artery or it may resemble a bulge with a wide or indistinct neck.  

The Pipeline Embolization Device (PED) is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that can be used to block off large, giant, or wide-necked aneurysms in the internal carotid artery, a major blood vessel supplying blood to the front of the brain. The device can also reduce the likelihood that an aneurysm will rupture.  

To implant the device, the Pipeline is attached to the end of a catheter, which is inserted into an artery in the leg. The catheter is threaded into the carotid artery and into position at the aneurysm where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm, cutting off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot which reduces the likelihood the aneurysm will grow bigger or rupture. Aneurysms successful
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SOURCE U.S. Food and Drug Administration
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