Inari Medical's FlowTriever System Cleared by FDA to Treat Pulmonary Embolism

May 21, 2018—Inari Medical, Inc. announced that its FlowTriever thrombectomy system has received US Food and Drug Administration 510(k) clearance for the treatment of pulmonary embolism (PE).

According to the company, the PE-specific clearance was based on the strength of the recently released results from the FlowTriever Pulmonary Embolectomy (FLARE) clinical study. The prospective, multicenter, single-arm FLARE study is 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 (right ventricular/left ventricular [RV/LV] ratio ≥ 0.9) were eligible to participate. Treatment with the FlowTriever system was used to nonsurgically 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 < .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.

In the company's announcement, FLARE study investigator Wissam Jaber, MD, commented, "The FlowTriever system is an exciting advancement in the treatment of acute pulmonary embolism patients. Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications. The FlowTriever system represents a breakthrough in treatment options for this large patient population." Dr. Jaber is with Emory University Hospital in Atlanta, Georgia.