The device has CE Mark indication for treating cerebral aneurysms via endovascular embolization. The original Pipeline device has been on the European market since 2009 and the next-generation Pipeline Flex won CE Mark earlier this year. The Flex model is not currently available in the U.S., but the original Pipeline won FDA approval in 2011.
The device is designed to cut off blood flow to an aneurysm, featuring braided mesh tubing and release mechanisms that Covidien says make Pipeline Flex easier to position and place.
"The Pipeline Flex embolization device is the next advancement in flow diversion, combining our clinically-proven braid design with a new delivery system designed to offer even more accuracy and control when performing these advanced procedures inside the brain," Covidien neurovascular president Brett Wall said in prepared remarks. "Covidien is dedicated to seeking customer feedback and advancing product design to meet their needs."
Covidien announced the launch during this week’s Live Interventional Neuroradiology & Neurosurgery Course in Paris.