Inari Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its FlowTriever system to treat pulmonary embolism and right atrial clot in transit (CIT).
CIT is a severe condition that occurs when a deep vein thrombosis (DVT) breaks loose and embolises to the right heart. The right atrial CIT is associated with more than 80% mortality rate if left untreated.
Inari Medical is a commercial-stage medical device company focused on venous-specific devices, developing products for the treatment of patients suffering from venous diseases.
The company has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices ClotTriever system and FlowTriever system to remove large clots from large vessels and eliminate the need for thrombolytic drugs.
ClotTriever system has been granted FDA 510(k) approval and CE Mark approval for the treatment of deep vein thrombosis.
Inari chief executive officer Bill Hoffman said: “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.
“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.”
FlowTriever eliminates need for cardiopulmonary bypass circuit
The medical device firm claimed that its FlowTriever is the first thrombectomy system that eliminates the need for FDA approved cardiopulmonary bypass circuit for treating CIT in right atrium.
Interventional cardiologists Dr. Gautam Kumar and Dr. Rajesh Sachdeva recently co-authored a case series on their experience using FlowTriever right atrial CIT.
The catheterisation and cardiovascular intervention of the device is studied at Emory and Morehouse Schools of Medicine and their affiliated hospitals, respectively, said the company.
Dr. Kumar said: “Right atrial CIT is a serious condition requiring urgent intervention, yet no single best treatment modality has been established.
“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.”
