May 7, 2019
Inari Medical Announces Publication of Results From the FLARE IDE Study
May 7, 2019—Inari Medical, Inc. announced that results from the 106-patient, prospective, multicenter FLARE investigational device exemption study of the company's FlowTriever mechanical pulmonary embolectomy device were published by Thomas Tu, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2019;12:859–869).
The study of the treatment of intermediate-risk pulmonary embolism (PE) was led by Coprincipal Investigators, Kenneth Rosenfield, MD, and Victor Tapson, MD. In May 2018, the FDA cleared FlowTriever for the treatment of PE and the nonsurgical removal of thrombus from the peripheral vasculature.
According to the company, the study met both of its primary safety and effectiveness endpoints, showing large and rapid reduction in right heart strain. There were no device-related major adverse events, and only two of the 106 patients enrolled received thrombolytic drugs.
The study also showed that patients treated with FlowTriever had much shorter stays in intensive care units and shorter overall lengths of stay compared to previously published studies in which thrombolytic drugs were used to treat PE.
In the company's announcement, Dr. Tu stated, "The results of this trial open the door to an entirely new approach to the treatment of pulmonary embolism. It is exciting to be able to offer this potentially life-saving therapy to our patients." Dr. Tu is Director of the Pulmonary Embolism Response Team at Baptist Health Louisville in Louisville, Kentucky.
In December 2018, Inari Medical announced the commencement of patient enrollment in the FLASH registry, which is evaluating patients with intermediate- and high-risk PE treated with FlowTriever and followed over the short and intermediate term.
"With FLARE complete and the data now published, we are excited to collect a larger set of real-world data on FlowTriever via the FLASH registry," stated FLASH Principal Investigator Catalin Toma, MD, in Inari Medical's press release.