FLARE Study of Inari Medical's FlowTriever for Pulmonary Embolism Completes Enrollment
October 24, 2017—Inari Medical, Inc. recently announced that it has completed enrollment of the FLARE study, which is designed to evaluate the safety and effectiveness of the company's FlowTriever retrieval/aspiration system for the treatment of pulmonary embolism. The prospective, multicenter, single-arm study is evaluating the FlowTriever in 106 patients with acute pulmonary embolism at 18 sites in the United States.
Ken Rosenfield, MD, and Victor Tapson, MD, are Coprincipal Investigators of the FLARE study, which is being conducted under an investigational device exemption from the US Food and Drug Administration (FDA). FDA approval of the trial's investigational device exemption was announced in March 2016.
The FlowTriever device has received FDA 510(k) clearance for thrombectomy in the peripheral vessels. Use for the treatment of pulmonary embolism is investigational. The device has not been cleared in the United States for this specific use, advised Inari Medical.
In the company's announcement, Dr. Rosenfield commented, “The completion of the FLARE study marks an exciting advancement in the treatment of acute pulmonary embolism patients. Until now, there has not been a percutaneous approach to rapidly restore flow to reverse right heart strain without the without the use of thrombolytic drugs and the associated risk of bleeding complications.”
Dr. Tapson added, “Completion of enrollment is the result of strong collaboration between a talented group of physician investigators. We appreciate their dedication and expertise in evaluating the first thrombectomy device designed specifically to treat pulmonary embolism."
According to the company, the FlowTriever 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 is a privately held, venture-backed medical device company dedicated to the development of catheter-based technologies for the treatment of venous thromboembolism. The company is developing solutions for removing large clot volume from big vessels without the use of thrombolytic drugs.