Research & Development
MicroVention passes FDA premarket approval for FRED for brain aneurysms treatment
10 January 2020 -

MicroVention Inc revealed on Thursday the receipt of Premarket Approval (PMA) from the US Food and Drug Administration (FDA) for its FRED (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms.

According to the company, the FRED device is the first flow diverter in the US to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion. The unique interwoven nitinol design of the FRED device allows for smooth delivery to the target aneurysm, as well as reliable opening and vessel wall apposition, resulting in high treatment durability.

The Flow Re-Direction Endoluminal Device (FRED) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients with wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

In addition, the company said the FRED device has been CE marked since 2013, safely used in nearly 20,000 procedures and published in numerous clinical studies around the world.

MicroVention is a global neurovascular company and the US subsidiary of Japan-based Terumo.

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