Wednesday, February 23, 2022
MicroVention, Inc., a subsidiary of Terumo and a global neurovascular company, announced the first U.S. clinical case of its next generation Flow Diverter, the FRED X device, at Thomas Jefferson University Hospital located in Philadelphia. MicroVention received FDA PMA approval for the FRED X device in September of last year. The FRED X Flow Diverter features MicroVention X Technology, a proprietary nano-polymer surface modification designed to reduce material thrombogenicity, or tendency for clot formation on the device surface.
Building on the original FRED device, which received FDA PMA approval in 2019, the FRED X device uses a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion. With the addition of X Technology, FRED X is designed to reduce thrombogenicity of the device material and enhance blood vessel healing. FRED X offers both the smallest and largest flow diversion systems available in the U.S., providing physicians with the broadest range of options for treating their patients.
"FRED X represents an important advancement in flow diversion therapy. 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," said Dr. Stavropoula Tjoumakaris, Director, Endovascular Surgery and Cerebrovascular Neurosurgery Fellowship at Thomas Jefferson University Hospital, and principal investigator of the FRED X [post approval] study. "We are excited to be the first center in the U.S. to have clinical experience using the FRED X device and look forward to a clinical study on the benefits of X Technology."
An estimated 6.5 million people [or 1 in 50 people] in the U.S. have an unruptured brain aneurysm, approximately 300,000 of which will rupture, potentially leading to disability or death. Since it received the CE Mark in 2013, the FRED device has been used to treat tens of thousands of patients and its safety and effectiveness have been shown in dozens of clinical publications.
"At MicroVention, we continue to enhance our product portfolio to make meaningful improvements in patient care," said Carsten Schroeder, President and CEO of MicroVention. "Surface treatment technologies, such as the FRED X device, represent the next frontier in neurovascular therapy, and MicroVention is proud to be able to offer the first of several devices incorporating our X Technology to physicians and patients in the U.S."
