The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment of PE. The FlowTriever had previously been cleared for treatment of the peripheral vasculature.

Inari announced that the PE specific clearance was based on the results from the FlowTriever Pulmonary Embolectomy (“FLARE”) study. Principal investigator Dr. Thomas Tu presented the results of the FLARE study at an April 27, 2018 Scientific Session of the Society for Cardiovascular Angiography and Interventions in San Diego, CA. In a press conference, Dr. Tu stated that the FlowTriever “potentially has the chance to reduce bleeding complications, [and] to reduce total hospital and ICU length of stay.” Dr. Tu also emphasized that the FlowTriever compared favorably with other techniques for treating PE and that FlowTriever employs a “purely mechanical approach which avoids the use of thrombolytic drugs and [the] resulting risk of of bleeding complications” associated with other techniques. Co-principal investigator Dr. Victor Tapson touted the results as “an exciting advancement in the treatment of acute pulmonary embolism patients” because “[u]ntil 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.”

A recent article from the American College of Cardiology estimates that approximately 100,000 hospitalized patients each year die of causes related to PE. The article discusses other treatments for PE, including anticoagulants and inferior vena cava filters. The article also discusses other percutaneous approaches for treatment of PE such as “1) thrombus fragmentation with a rotating pigtail catheter; 2) aspiration thrombectomy; 3) rheolytic thrombectomy; and 4) suction embolectomy.”

The FlowTriever is a mechanical device designed “to treat vascular occlusions due to an embolis[m].” The FlowTriever catheter has a self-expanding retriever with three “disks” for engagement and retraction of clots. The retriever is designed to self-expand with a clot, engaging the clot and trapping it between the disks. The clot is retracted into an “aspiration guide catheter,” allowing for synchronized aspiration and mechanical retraction of the clot. Additional information on the FlowTriever is available in the video below from Inari Medical.