FDA Clears Inari Medical’s FlowTriever System for Treatment of Right Atrial Clot in Transit

January 8, 2021—Inari Medical announced FDA 510(k) clearance of the company’s FlowTriever system for the treatment of clot in transit (CIT) in the right atrium. The FlowTriever thrombectomy system does not require a cardiopulmonary bypass circuit. CIT, a life-threatening condition, occurs when a deep vein thrombosis breaks loose and embolizes to the right heart.

The company noted that interventional cardiologists Gautam Kumar, MD, and Rajesh Sachdeva, MD, et al recently published 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 Atlanta, Georgia. The findings are available online ahead of print in Catheterization and Cardiovascular Interventions.

“Right atrial CIT is a serious condition requiring urgent intervention, yet no single best treatment modality has been established,” commented Dr. Kumar in the Inari Medical’s announcement. “Intervention has traditionally exposed critically ill patients to the risks of open heart surgery or thrombolytic drugs or required the set up 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.”

Inari Medical’s catheter-based mechanical thrombectomy devices are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The devices are specifically developed for the treatment of the two distinct manifestations of venous thromboembolism: deep vein thrombosis and pulmonary embolism.

The FlowTriever system is now 510(k)-cleared by the FDA for the treatment of pulmonary embolism and clot in transit in the right atrium. Inari’s ClotTriever system has received FDA clearance and European CE Mark approval for the treatment of deep vein thrombosis, noted the company.