Most recent update: Sunday, April 29, 2018 - 14:56

You are here

FLARE study

Inari completes patient enrolment in the FLARE study for PE

The 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

Inari Medical has completed patient enrolment in its Investigational Device Exemption (IDE) FlowTriever Pulmonary Embolectomy Clinical Study (FLARE) study, designed to evaluate the safety and effectiveness of the FlowTriever Retrieval/Aspiration System for the treatment of pulmonary embolism.

The 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 completion of the FLARE study marks an exciting advancement in the treatment of acute pulmonary embolism patients," said Dr Ken Rosenfield, Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and Co-Principal Investigator of the study.  "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." 

The FLARE study is a prospective, multi-centre, single-arm study evaluating the FlowTriever in 106 patients with acute pulmonary embolism at 18 sites in the US.

"Completion of enrolment is the result of strong collaboration between a talented group of physician investigators," said Dr Victor TapsonAssociate 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 enrolment of FLARE represents another major milestone for Inari," said Bill Hoffman, CEO of Inari Medical.  "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 system is cleared for thrombectomy in the peripheral vessels, however, use for the treatment of pulmonary embolism is investigational; the device has not been cleared in the US for this specific use.