FDA Approves Pipeline Flex Diversion Device for Aneurysm

Pipeline Flex
Pipeline Flex
The device came to market in June in Europe and will be available in the U.S. in the coming weeks.

The FDA today approved a new minimally-invasive flow diversion device for unruptured brain aneurysms. The Pipeline Flex embolization device from Medtronic will be available through a limited launch in the U.S. in the coming weeks.

The device, used to treat large and giant wide-necked brain aneurysms with a high risk of rupture, features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm, cutting off blood flow to the aneurysm and helping reconstruct the parent vessel.

The Pipeline Flex, a product from Medtronic’s Covidien group, is intended for the endovascular treatment of complex intracranial aneurysms that are not amendable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 and 5.0mm in diameter. The device is meant to give physicians more control and better placement.

This is the second Pipeline device approved by the FDA and follows European approval of the device back in June. The first-generation Pipeline device was approved in 2011 under Covidien prior to its acquisition by Medtronic. 

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