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www.fdanews.com/articles/165427-covidien-rolls-out-brain-aneurysm-device-in-europe

Covidien Rolls Out Brain Aneurysm Device in Europe

June 25, 2014

Irish devicemaker Covidien said Tuesday that its Pipeline Flex brain aneurysm-stopping device is now being marketed in Europe.

The minimally invasive, CE-marked Pipeline Flex averts blood flow away from an aneurysm when its cylindrical mesh tube is implanted across the base or neck of the weak spot, rebuilding the diseased section of the parent vessel.

According to Covidien, the device builds on the technology of the first-generation Pipeline embolization device, allowing for more accuracy, repositioning and controlled placement than its predecessor. Pipeline Flex’s instant braid release system makes it easier to place, the company says.

Pipeline Flex is not currently approved for use in the U.S. The first-generation Pipeline device was approved by the FDA in 2011 and is currently the only flow diversion device commercially available in the U.S., the devicemaker says. — Kellen Owings

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