MicroVention today announced that the first U.S. clinical case of its flow diverter Fred X device was performed at Thomas Jefferson University Hospital in Philadelphia.
Aliso Viejo, California-based MicroVention received premarket approval for the Fred X device in September. It uses a self-expanding braided nitinol mesh to redirect blood flow and promote aneurysm occlusion. The added X technology reduces the thrombogenicity of the device material and enhances blood vessel healing.
“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,” Stavropoula Tjoumakaris, director of end-vascular surgery and cerebrovascular neurosurgery fellowship at Thomas Jefferson University Hospital and principal investigator of the Fred X post-approval study, said in a news release. “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.”
The company’s first iteration of the device, Fred, has been used to treat tens of thousands of patients, according to MicroVention. It received CE mark approval in 2013.
“At MicroVention, we continue to enhance our product portfolio to make meaningful improvements in patient care,” CEO Carsten Schroeder said. “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.”