Inari Medical's FlowTriever Studied for Treatment of Pulmonary Embolism

May 1, 2018—Inari Medical, Inc. recently announced that results from the FLARE clinical study were presented by Thomas Tu, MD, at the 2018 scientific sessions of the Society for Cardiovascular Angiography and Interventions, held April 25–28 in San Diego, California.

The FLARE study evaluated the safety and effectiveness of the company's FlowTriever retrieval/aspiration system for the treatment of pulmonary embolism (PE). The prospective, multicenter, single-arm study was composed of 106 patients with acute PE at 18 sites in the United States.

Patients with proximal PE and right heart strain (right ventricular–to–left ventricular [RV/LV] ratio ≥ 0.9) were eligible to participate. Treatment with the FlowTriever system was used to mechanically remove blood clots in the pulmonary arteries.

Inari Medical reported that in the study, the mean RV/LV ratio 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 the device's safety at 30 days, with a 3.8% rate of major adverse events and no device-related complications. Median intensive care unit stay was 1 day, and overall median length of hospital stay was 3 days.

In the company's announcement, Dr. Tu commented, "The significant improvement in right heart function shown with the FlowTriever system compares very favorably with outcomes of other techniques used to treat PE. At the same time, the impressive safety profile reflects the advantages of FlowTriever’s purely mechanical approach which avoids the use of thrombolytic drugs and resulting risk of bleeding complications.”

Ken Rosenfield, MD, and Victor Tapson, MD, are the Coprincipal Investigators of the study.

Dr. Rosenfield stated in the company's press release, "The FlowTriever system represents a breakthrough in treatment options for this large patient population. These results indicate that mechanical thrombectomy with the FlowTriever system will play an increasing role in the management of pulmonary embolism.”

Dr. Tapson added, “The results of the FLARE study mark 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.”