FDA Approves PED Device to Treat Brain Aneurysms

Emma Hitt, PhD

April 07, 2011

April 7, 2011 — A new device for treating brain aneurysms that spares the need for open surgery has been approved by the US Food and Drug Administration (FDA).

According to Christy Foreman of the Office of Device Evaluation, Center for Devices and Radiological Health, the Pipeline embolization device (PED) "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 PED, manufactured by ev3, is a flexible mesh tube made of nickel-cobalt chromium alloy and platinum. The device can block giant and wide-necked aneurysms in the carotid artery that supplies blood to the brain. Furthermore, the PED reduces the chance that the aneurysm will rupture.

The PED is implanted via attachment to the end of a catheter that is inserted into an artery in the leg. The catheter is then navigated into the carotid artery, to the aneurysm. At this point, the PED is expanded to obstruct blood flow to the aneurysm. Any remaining blood in the obstructed aneurysm forms a clot. This reduces the likelihood of rupture and often causes the aneurysm to shrink.

On March 21, the FDA's Neurological Devices panel voted unanimously to recommend approval for the device. During the approval process, the FDA reviewed study results showing that 70% of aneurysms remained obstructed, without significant arterial stenosis 1 year after PED implantation.

Participating in the study were 108 patients age 21 to 75 years with a large or giant aneurysm that had no apparent neck and was located in the internal carotid artery. Adverse events were recorded: Ten strokes occurred in 9 patients 1 year after PED implantation. The stroke rate was significantly less than the 20% rate expected. Minor adverse events, such as nausea, headache, bleeding, and vision problems, were reported.

The PED is contraindicated in patients with an active infection and patients unable to take antiplatelet therapy, such as aspirin. Patients should receive adequate antiplatelet therapy before implantation of the device. The PED should not be used to treat a previously stented aneurysm.

Approximately 30,000 people in the United States experience ruptured aneurysms each year, according to the American Association of Neurological Surgeons. Aneurysms are more prevalent in women and in people age 50 to 60 years.

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