Inari Medical said today that the FDA granted pre-market approval in February for its ClotTriever thrombectomy device Feb. 16 and already has the 1st commercial procedure under its belt.
Irvine, Calif.-based Inari said the ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature. The company also makes the FlowTriever device, which is designed to retrieve pulmonary embolisms.
“The ClotTriever system is the 2nd product offering in Inari’s product portfolio,” CEO Bill Hoffman said in prepared remarks. “The ClotTriever is currently available for treatment of thrombus in the peripheral veins at select centers, and we plan to add more centers as we gain clinical experience. We are pleased to provide a new tool for interventionalists to treat patients with large blood clots in big vessels, while avoiding the need for, and risk of, thrombolytic drugs.”
“We are pleased to be the first site to perform a procedure using the ClotTriever system. The ClotTriever removed clot in the iliac vein efficiently, and without the need for thrombolytic drugs,”
Last year Inari won an investigational device exemption from the FDA for a clinical trial of the FlowTriever device, the 150-patient Flare study, with a primary safety endpoint of major adverse events within 48 hours and an efficacy endpoint of reduction in right ventricle/left ventricle ration from baseline to 48 hours. The Flare trial is slated to close in November, with final data collection for the primary outcome in September, according to ClinicalTrials.gov.