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Neuroscience: New Brain Aneurysm Device Approved

by Erin Moore

The U.S. Food and Drug Administration (FDA) has approved a new device for the treatment of carotid artery brain aneurysms. The Pipeline Embolization Device, manufactured by ev3 of Menlo Park, California, provides physicians with an alternative to open surgery and the placement of materials such as coils or a liquid embolic.

The Pipeline is indicated for large, giant, or wide-necked aneurysms in the internal carotid artery. It is a flexible mesh tube consisting of platinum and nickel-cobalt chromium alloy. For implantation, it is attached to the end of a catheter, which is inserted into a leg artery. Once threaded into the carotid and into position, it is expanded against the walls of the artery and across the neck of the aneurysm, blocking blood flow.

Approval is based on a study of 108 people ranging from 21 to 75 years. After one year, 70 percent of aneurysms remained blocked off, without stenosis, and many had shrunk. Stroke occurred in .08 percent (nine) of the patients, which is a significantly lower percentage than expected for this condition. The Pipeline is contraindicated in patients with active infection and in those who cannot take antiplatelets (antiplatelet therapy is advised prior to implantation).

Source: Food and Drug Administration. 2011. FDA approves new device to treat brain aneurysms. Published on April 6, 2011 on the FDA website.