Inari Medical Announces First Use of FlowTriever Infusion Aspiration System After FDA Clearance
March 12, 2015—Inari Medical Inc. announced that its FlowTriever infusion aspiration system, which received 510(k) marketing clearance from the US Food and Drug Administration (FDA) in February to treat emboli in the peripheral vasculature, was used for initial treatment of a patient.
Tod Engelhardt, MD, Chairman of the Cardiovascular and Thoracic Surgery Division of East Jefferson General Hospital in Metairie, Louisiana, commented in the company’s press release, “We are pleased to be the first site to perform a procedure using the FlowTriever system. The FlowTriever offered an efficient, minimally invasive treatment and rapidly restored blood flow in the occluded vessel. I believe the FlowTriever is a promising new advancement in the treatment of vessels occluded by emboli.”
According to Inari Medical, the FlowTriever system is composed of three components that work in concert. The FlowTriever catheter has a self-expanding nitinol framework that is designed to engage, disrupt, and remove emboli from blood vessels with minimal trauma. The flexible, large-bore (20 F) aspiration guide catheter facilitates the delivery, positioning, and deployment of the FlowTriever catheter and provides exceptional aspiration capability. The retraction aspirator provides a vacuum for aspiration during FlowTriever retraction to enhance its effectiveness in restoring blood flow. The entire system is designed for use over a standard exchange-length, 0.035-inch guidewire, advised the company.