FLASH Registry Evaluates Inari's FlowTriever System for Pulmonary Embolism
December 6, 2018—Inari Medical, Inc. announced the commencement of enrollment in the all-comers FLASH registry studying the safety and hemodynamics of the company's FlowTriever system for the treatment of pulmonary embolism (PE).
FLASH is a 500-patient, prospective, multicenter registry evaluating real-world outcomes after treatment of patients with intermediate and high-risk PE with FlowTriever.
According to the company, FLASH follows the completion earlier in 2018 of FLARE, a clinical study that evaluated the use of the FlowTriever for treatment of PE, and the recent launch of CLOUT, an outcomes registry evaluating outcomes after treatment of deep vein thrombosis with Inari's ClotTriever system.
The FlowTriever system is 501(k) cleared by the FDA for the treatment of PE and for the nonsurgical removal of thrombus from the peripheral vasculature. The ClotTriever system is 510(k) cleared for thrombectomy in the peripheral vessels.
The FLASH study is led by Principal Investigator Catalin Toma, MD, Interventional Cardiologist at UPMC Presbyterian in Pittsburgh, Pennsylvania. The registry's first patient was enrolled by Thomas M. Tu, MD, Director of the Pulmonary Embolism Response Team at Baptist Health Louisville in Louisville, Kentucky.
In the company's press release, Dr. Toma commented, "Compared to the previous FLARE study, FLASH will allow us to evaluate both short- and long-term outcomes in a much broader group of patients. In particular, the 6-month follow-up will allow us to determine how significant clot removal improves cardiac hemodynamics, symptoms, and quality-of-life metrics over the longer term."
Dr. Tu stated, "We are pleased to be the first site to enroll a patient in FLASH. In our experience, the FlowTriever system consistently and safely removes large volumes of clot from the pulmonary arteries, allowing us to improve heart function while avoiding the need for thrombolytic drugs and their associated bleeding risk. FlowTriever is the only mechanical thrombectomy device indicated for the treatment of PE and has become our first line therapy."