A new platinum embolization device for use in brain surgery has been granted approval from the US Food and Drug Administration (FDA).

Covidien said its Pipeline Embolization Device can now go on sale in the US after the FDA's Neurological Devices Advisory Panel recommended the platinum instrument get the go-ahead.

It is a new class of embolization device intended for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.

Aaron Berez from Covidien explained that the safe and effective treatment of these types of aneurysms remains "a significant unmet clinical need".

"Clinical experience suggests that the Pipeline Embolization Device may represent a valuable alternative to current endovascular or surgical treatment options for these types of aneurysms," he added.

The device has already received CE Mark approval in Europe and has been on sale outside the US since July 2009.

FDA approval was based on the results of a clinical study on 108 patients that showed it to be both safe and effective.

Source:

Covidien Announces FDA Advisory Committee Unanimously Recommends Approval for Pipeline™ Embolization Device (18/03/11)

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