FLARE Will Study Inari’s FlowTriever System to Treat Pulmonary Embolism
March 8, 2016—Inari Medical, Inc. announced that the US Food and Drug Administration has approved an investigational device exemption for a study to evaluate the safety and effectiveness of its FlowTriever retrieval/aspiration system.
According to the company, the FlowTriever Pulmonary Embolectomy (FLARE) clinical study is approved to begin enrollment of patients at up to 20 sites in the United States. FLARE will evaluate the safety and effectiveness of the FlowTriever system for use in the removal of emboli for the treatment of acute pulmonary embolism.
The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever in 150 patients with acute pulmonary embolism. The study will be conducted at up to 20 investigational sites in the United States. Currently, study activities are underway at more than 15 sites, with patient enrollment anticipated over the coming weeks.
The FlowTriever system is a catheter-based mechanical thrombectomy device for percutaneous endovascular retrieval of emboli from the peripheral vasculature and is intended for use in the proximal pulmonary arterial system in patients with acute pulmonary embolism. Treatment with the FlowTriever does not require the use of thrombolytics, noted Inari Medical.
Ken Rosenfield, MD, and Victor Tapson, MD, are the Coprincipal Investigators of the FLARE study. Dr. Rosenfield is Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts. Dr. Tapson is Associate Director, Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles, California.
In the company’s press release, Dr. Rosenfield commented, “This study of the FlowTriever system will enhance our understanding of the patients best suited for rapid intervention.”
Dr. Tapson added, “The initiation of the FLARE study represents an important milestone for this exciting new endovascular tool and a critical step towards improving outcomes in a patient population with few treatment options. I look forward to collaborating with a talented group of physician investigators.”
In March 2015, Inari Medical announced the first commercial use after US Food and Drug Administration clearance of the FlowTriever infusion aspiration system to treat emboli in the peripheral vasculature.