The US Food and Drug Administration (FDA) has approved a new device made of a platinum and nickel-cobalt chromium alloy to treat brain aneurysms without performing open surgery.

Manufactured by ev3, the Pipeline Embolization Device (PED) is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy used to block off large, or wide-necked aneurysms in the internal carotid artery.

Aneurysms are a weak, enlarged area of a blood vessel, which can rupture and are potentially life-threatening.

According to the American Association of Neurological Surgeons, 30,000 people in the US experience a ruptured brain aneurysm every year.

The FDA gave the PED the green light after a study showed that one year after implantation, 70 percent of aneurysms remained blocked off without significant narrowing of the section of the artery treated with the device.

Some 108 patients were followed over the course of the study. Strokes occurred in nine of these in the year after treatment, well below the 20 per cent rate expected for the condition.

Patients did experience some "minor adverse" side effects, such as headache, bleeding, nausea and vision problems.

The FDA report noted that the effectiveness of the PED was met with "a very high degree of statistical significance".

Christy Foreman, acting director of the Office of Device Evaluation, Center for Devices and Radiological Health, said: "The Pipeline Embolization Device offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms."

The FDA report concluded by saying that evidence from "multiple sources" shows the PED is "safe and effective" and that "the benefits outweigh the risks".

It also noted that the device should not be used in patients with an infection or those who cannot take medication that interferes with blood clotting, such as aspirin.

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FDA approves new device to treat brain aneurysms (06/04/11) 

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