FDA grants 510(k) approval forFlowTriever System for treatment of pulmonary embolism.- Inari Medical Inc.

Inari Medical, Inc., has announced the FlowTriever System has received FDA 510(k) clearance for the treatment of pulmonary embolism (“PE”). This clearance makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.

The PE-specific clearance was based upon the strength of the recently released results from the FlowTriever Pulmonary Embolectomy (“FLARE”) Clinical Study. The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever System in 106 patients with acute PE at 18 sites in the United States. Patients with proximal PE and right heart strain (RV/LV ratio ? 0.9) were eligible to participate. Treatment with the FlowTriever System was used to non-surgically remove blood clots in the pulmonary arteries without the need for thrombolytic drugs. The mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours postprocedure, a difference of 0.39 (p<0.0001). The study also demonstrated excellent safety at 30 days, with a low 3.8% rate of major adverse events and no device related complications.