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Tuesday, April 12, 2011

FDA Approves PED Device to Treat Brain Aneurysms


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 Pipelineembolization 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 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.

source:medscape

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