FlowTriever is the first thrombectomy device cleared for the treatment of pulmonary embolism.
Today Inari Medical, Inc. announced that the FlowTriever System has received US Food and Drug Administration (FDA) 510(k) clearance for the treatment of pulmonary embolism (PE). It is the first thrombectomy device cleared by the FDA for that indication.
The device allows for the non-surgical removal of blood clots in the pulmonary arteries without the use of thrombolytic drugs and the accompanying risk of bleeding complications.
Results from the recently released FlowTriever Pulmonary Embolectomy ("FLARE") clinical study supported the FDA’s decision. The prospective, multicenter, single-arm study evaluated 106 patients with acute pulmonary embolism at 18 sites in the United States.
"The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients," Wissam Jaber, MD, Emory University Hospital and FLARE clinical study investigator said in a statement. "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."
The FLARE study included patients with proximal PE and right heart strain (RV/LV ratio ≥ 0.9). At 48 hours following the procedure, the mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15, a difference of 0.39 (p<0.0001).
The study also reported an excellent safety outcome, with a 3.8% rate of major adverse events. There were no reported complications relating to the device use.
"The FLARE data and resulting PE-specific clearance reflects the diligent work of a talented group of physician investigators," said Inari Medical CEO Bill Hoffman. "This marks another major milestone for Inari towards our goal of transforming the treatment of venous thromboembolism by developing solutions for removing large clot volume from big vessels without the use of thrombolytic drugs."
In addition to FlowTriever, which is indicated for the treatment of pulmonary embolism, Inari Medical also manufactures the ClotTriever System, a 510(k) cleared device for thrombectomy in the peripheral vessels.