Inari Medical has announced US 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 embolises to the right heart. Around 25,000 patients are diagnosed with right atrial CIT in the USA 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.
Interventional cardiologists Gautam Kumar and Rajesh Sachdeva recently co-authored a case series on the successful FlowTriever right atrial CIT experience they have had respectively at Emory and Morehouse Schools of Medicine and their affiliated hospitals, 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,” said Kumar. “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 anaesthesia. 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 thromboembolism (“VTE”) patients,” said Bill Hoffman, Inari’s chief executive officer. “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.”