Two weeks after having an FDA panel recommend its Pipeline Embolization Device, Covidien‘s ev3 unit has received Premarket Approval (PMA) from the regulatory agency. The device is intended for treatment of “large or giant wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.” The Pipeline obtained European clearance back in July 2009.
From the product page:
Flow Re-Direction
• 85% reduction in circulation within aneursym
• 3-5 fold increase in surface coverage compared to intracranial stentsTreat in Difficult Anatomy
• Flexibility allows it to be delivered and used in tortuous anatomyTreat Thin Walled Aneurysms
• Because PED is not an intrasaccular therapy, you can treat even thin walled aneurysmsCustom Coverage
• The ability to place multiple devices, one inside another allows customized constructs with variable degrees of aneurysm coverage and flow disruptionBranch Vessel Preservation
• Optimized surface coverage ratio provides flow diversion from the aneurysm but preserves flow in perforators or branch vesselsEndothelial Re-Pavement
• Bimetallic microfabricate braid provides a flexible yet supportive structure across the aneurysm neck
• Scaffolding promotes endothelial re-pavement, excluding the aneurysm from circulation
Press release: Covidien Receives FDA Premarket Approval for Pipeline(R) Embolization Device
Product page: Pipeline Embolization Device…
Flashback: Pipeline Embolization Device Gets FDA Panel Recommendation