MicroVention’s Fred X Flow Diverter Used in First US Postapproval Case

February 22, 2022—MicroVention, Inc., a subsidiary of Terumo, announced the United States introduction of the company’s next-generation Fred X flow diverter. The first clinical case in the United States was performed at Thomas Jefferson University Hospital in Philadelphia Pennsylvania.

Stavropoula Tjoumakaris, MD, serves as Principal Investigator of the FRED X postapproval study and is Director of Endovascular Surgery and Cerebrovascular Neurosurgery Fellowship at Thomas Jefferson University Hospital.

The Fred X device is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (aged ≥ 22 years) 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.

According to the company, the Fred X device features MicroVention’s X technology, which is a nanopolymer surface modification designed to reduce material thrombogenicity.

MicroVention received FDA premarket approval for the Fred X device in September 2021. The Fred X builds on the original Fred device, which received FDA approval in 2019 and European CE Mark approval in 2013.

The new device uses a self-expanding braided nitinol mesh to help redirect blood flow and promote aneurysm occlusion. With the addition of X technology, Fred X, which offers both small and large flow diversion systems, is designed to reduce thrombogenicity of the device material and enhance blood vessel healing.

“Fred X represents an important advancement in flow diversion therapy,” commented Dr. Tjoumakaris in the company’s press release. “The X technology surface treatment applied to the Fred X device is designed to reduce material thrombogenicity and has further increased the deliverability of the Fred X. We are excited to be the first center in the United States to have clinical experience using the Fred X device and look forward to a clinical study on the benefits of X technology.”