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Inari Medical, Inc., a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism (“VTE”), announced today it has completed enrollment of its Investigational Device Exemption (“IDE”) study. The FlowTriever Pulmonary Embolectomy Clinical Study (“FLARE”) study is designed to evaluate the safety and effectiveness of the FlowTriever Retrieval/Aspiration System for the treatment of pulmonary embolism.
Ken Rosenfield, MD, Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and Co-Principal Investigator of the study notes: “The completion of the FLARE study marks an exciting advancement in the treatment of acute pulmonary embolism patients.” Dr. Rosenfield went on to say, “Until now, there has not been a percutaneous approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and the associated risk of bleeding complications.”
“Completion of enrollment is the result of strong collaboration between a talented group of physician investigators,” added Victor Tapson, MD, Associate Director, Pulmonary and Critical Care Division, Cedars-Sinai Medical Center, Los Angeles and Co-Principal Investigator of the study. “We appreciate their dedication and expertise in evaluating the first thrombectomy device designed specifically to treat pulmonary embolism”.
“Finishing enrollment of FLARE represents another major milestone for Inari,” said CEO Bill Hoffman. “We are encouraged by our investigators’ enthusiasm for the FlowTriever System and commitment to enrolling the study so efficiently. The FLARE study reflects Inari’s focus on transforming the treatment of VTE by developing solutions for removing large clot volume from big vessels without the use of thrombolytic drugs”.
The FlowTriever Retrieval/Aspiration System (“FlowTriever System”) is a catheter-based mechanical thrombectomy device for percutaneous endovascular retrieval and disruption of emboli from the peripheral vasculature without the need for thrombolytics.
The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever in 106 patients with acute pulmonary embolism at 18 sites in the United States. More information on the FLARE study can be found here under NCT#02692586.