The FDA has granted 510(k) clearance for the Inari Medical Inc. FlowTriever system for the treatment of clot in transit (CIT) in the right atrium. FlowTriever is the first thrombectomy system not requiring a cardiopulmonary bypass circuit to be FDA cleared for blood clots in the right atrium.
January 8, 2021 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Inari Medical Inc. FlowTriever system for the treatment of clot in transit (CIT) in the right atrium.
FlowTriever is the first thrombectomy system not requiring a cardiopulmonary bypass circuit to be FDA cleared for blood clots 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 percent if left untreated.
Interventional cardiologists Gautam Kumar, M.D., Emory, and Rajesh Sachdeva, M.D., Morehouse School of Medicine, recently co-authored a case series on the successful FlowTriever right atrial CIT experience they had, it was published in Catheterization and Cardiovascular Intervention, the official journal of the Society for Cardiovascular Angiography and Interventions (SCAI).
“Right atrial CIT is a serious condition requiring urgent intervention, yet no single best treatment modality has been established,” Kumar said. “Intervention has traditionally exposed critically ill patients to the risks of open-heart surgery or thrombolytic drugs, or required the setup of complex bypass circuits by specialized perfusion staff in an operating room under general anesthesia. FlowTriever offers an exciting new treatment option to safely remove clot from the right atrium in a short, single session procedure without general anesthesia while avoiding the bleeding risks of thrombolytics.”
“This expanded indication for FlowTriever is the latest testament to Inari’s comprehensive and long-term commitment to the care of venous thrombo-embolism (VTE) patients,” said Bill Hoffman, Inari CEO. “We remain committed to revolutionizing VTE treatment with devices that remove large clot volume from large vessels, now including within the heart, while completely eliminating lytics and their consequent cost, ICU stay, and bleeding complications.”
Inari has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by the FDA and CE mark approved for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA for the treatment of pulmonary embolism and clot in transit in the right atrium.
1. Isha Verma, Eric Y Chang, Gautam Kumar, Rajesh Sachdeva. Catheter directed embolectomy of right atrial clot in transit ‐ A case series. Catheterization and Cardiovascular Intervention. First published online 23 November 2020. https://doi.org/10.1002/ccd.29391