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January 9, 2020

FDA Approves MicroVention’s Fred Flow Diverter for the Treatment of Intracranial Aneurysms

January 9, 2020—MicroVention, Inc., a United States–based subsidiary of Terumo, announced FDA premarket approval for the Fred (flow-redirection endoluminal device) system for the treatment of intracranial aneurysms. The Fred system received European CE Mark approval in 2013.

According to MicroVention, the Fred flow diverter uses a self-expanding, braided nitinol mesh to help redirect blood flow and promote aneurysm occlusion. The 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 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 (≥ 22 years old) 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 mm and ≤ 5 mm.

Cameron McDougall, MD, Director of Endovascular Neurosurgery and Professor of Neurosurgery at The Johns Hopkins Hospital in Baltimore, Maryland, commented in MicroVention’s announcement, “The Fred device represents a step forward in flow diversion technology with the inclusion of the lowest-profile delivery platform in the United States. This advancement will allow physicians to more easily access and treat wide-necked or fusiform aneurysms.” Dr. McDougall serves as the Primary Investigator for FRED pivotal trial.

He further noted, “The pivotal study shows that a single Fred device is safe and effective for use in a variety of aneurysm sizes and locations and expands treatment options for patients."

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