Medtronic to Launch Aneurysm Treatment Device, Following FDA Approval

Tuesday, February 17, 2015

Source: FDA News

Medtronic said Friday that the FDA approved its Pipeline Flex embolization device for diverting blood flow away from large and giant brain aneurysms. The device will be available in the U.S. in the coming weeks.

Pipeline Flex features a braided cylindrical mesh tube that is implanted across the base of the aneurysm, cutting off blood to the aneurysm and reshaping the diseased section of the parent vessel, the Irish devicemaker said. The innovative delivery system is expected to improve endovascular treatment and care.

The device is indicated for intracranial aneurysms that aren’t treatable with surgical clipping and are attached to parent vessels measuring 2.5 mm to 5 mm in diameter. Pipeline Flex joins Medtronic’s first-generation Pipeline embolization device, which has been available in the U.S. since 2011.

Ruptured brain aneurysms kill about 500,000 people worldwide each year, half of them under 50 years of age, Medtronic said.

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