Microvention, a subsidiary of Terumo, has announced the first US clinical case using its next-generation flow diverter, the FRED X device, at Thomas Jefferson University Hospital (Philadelphia, USA). 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 US Food and Drug Administration (FDA) premarket approval in 2019—the FRED X device uses a self-expanding braided nitinol mesh to help redirect blood flow and promote aneurysm occlusion, according to a Microvention press release.
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 USA”, providing physicians with “the broadest range of options for treating their patients”, according to the release.
“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 Stavropoula Tjoumakaris (Thomas Jefferson University Hospital, Philadelphia, USA), principal investigator of the FRED X [post-approval] study. “We are excited to be the first centre in the USA to have clinical experience using the FRED X device and look forward to a clinical study on the benefits of X technology.”
Microvention received FDA premarket approval for the FRED X device in September of last year. And, since it received a European CE mark in 2013, the original 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, the release further states.