Inari Medical has announced the enrolment of the first patient in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) using the company’s FlowTriever System for the treatment of pulmonary embolism (PE).
FLASH is a 500-patient prospective, multicentre registry study to evaluate real-world outcomes after treatment of patients with intermediate and high risk PE with FlowTriever. FLASH represents the latest investment in a robust pipeline of clinical studies and follows the completion of the FlowTriever Pulmonary Embolectomy (FLARE) clinical study early this year and the recent launch of the ClotTriever Outcomes Registry (CLOUT) evaluating outcomes after treatment of deep vein thrombosis (DVT) with Inari’s ClotTriever system.
“We are pleased to be the first site to enrol a patient in FLASH,” said Thomas M Tu, director of the Pulmonary Embolism Response Team (PERT) at Baptist Health Louisville, USA. “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 thrombolytics 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.”
“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,” said Catalin Toma, interventional cardiologist at UPMC Presbyterian in Pittsburgh, USA and principal investigator for FLASH. “In particular, the six-month follow-up will allow us to determine how significant clot removal improves cardiac haemodynamics, symptoms and quality of life metrics over the longer term.”
“FLASH reflects Inari’s commitment to the production of clinical data to help advance the understanding and treatment of PE and we look forward to working with a dedicated group of physician investigators to execute this important study,” said Bill Hoffman, Inari’s chief executive officer. “We are also pleased to announce the achievement of another important milestone having treated our 1,000th patient this month, a testament to our physician community’s dedication to non-lytic based treatment of venous thromboembolism patients.”
