The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device instead of commonly used clot busters. According to the company, “the mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours post procedure, 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.”
Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms.
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