Inari Medical, Inc. Announces U.S. Food and Drug Administration Clearance of the FlowTriever system
January 08, 2021 at 08:00 am
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Inari Medical, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the FlowTriever system for the treatment of clot in transit (CIT) in the right atrium. CIT is a life-threatening condition which occurs when a deep vein thrombosis (“DVT”) breaks loose and embolizes to the right heart. 25,000 patients are diagnosed with right atrial CIT in the United States annually, and the condition is associated with a mortality rate of over 80% if left untreated. FlowTriever is the first thrombectomy system not requiring a cardiopulmonary bypass circuit to be FDA cleared for blood clots in the right atrium.
Inari Medical, Inc. is a medical device company. The Companyâs products primarily consist of ClotTriever and FlowTriever systems, which are catheter-based mechanical thrombectomy systems that are used for the treatment of the venous thromboembolism (VTE) deep vein thrombosis (DVT), and pulmonary embolism (PE). Its InThrill system is used for the removal of emboli and thrombi from the peripheral vasculature. The LimFlow system is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation. It also offers RevCore thrombectomy catheter, which is a thrombectomy device for venous stent thrombosis, Triever 16 Curve catheter, which is used for venous thrombus removal, and ClotTriever Bold catheter, which is used for DVT and the removal of acute and chronic clots in the peripheral vasculature. Its ClotTriever XL, which is a catheter for efficient clot removal with minimal blood loss.