Inari Medical has announced that it has completed enrolment 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.
“The completion of the FLARE study marks an exciting advancement in the treatment of acute pulmonary embolism patients,” stated 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.”
“Completion of enrolment is the result of strong collaboration between a talented group of physician investigators,” added Victor Tapson, 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 enrolment 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 venous thromboembolism by developing solutions for removing large clot volume from big vessels without the use of thrombolytic drugs”.
The FlowTriever Retrieval/Aspiration 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, multicentre, 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 at www.clinicaltrials.gov under NCT#02692586.