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Terumo's device to treat brain aneurysms gets US FDA approval

The U.S. Food and Drug Administration gave pre-market approval to Terumo Corp.'s FRED system to treat brain aneurysms — a bulge in a blood vessel of the brain.

The Japanese medical-device maker's product is the first blood flow director in the U.S. that uses self-expanding braided nitinol mesh to help re-direct blood flow and promote blocking or closing of an aneurysm, Terumo said in a statement.

FRED, which stands for the flow re-direction endoluminal device, was approved in the EU in 2013 and has been used in nearly 20,000 procedures.