Positive acute and long-term interim results from the first 500 pulmonary embolism (“PE”) patients enrolled in the FlowTriever Outcomes Registry (“FLASH”) were presented at TCT 2021 by Principal Investigator, Catalin Toma, MD, an Interventional Cardiologist at University of Pittsburgh Medical Center (UPMC) and an affiliated faculty member of the McGowan Institute for Regenerative Medicine.
FLASH is a prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever, developed by Inari Medical, Inc., a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
At 48 hours post procedure, the major adverse event rate and mortality rate were low, at 1.4% and 0.2%, respectively. None of the deaths or major adverse events were device related. Collectively, these PE patients experienced substantial on-table improvements in hemodynamics and symptoms, which translated to 6-month improvements in cardiac function, functional status, and quality of life measures. The outcomes were achieved while limiting utilization of hospital resources, with less than 4% of patients receiving adjunctive therapy and a median of 0 days in the ICU post procedure.
“These interim results reinforce the strong safety profile of the FlowTriever System in real-world PE patients, with substantial on-table clinical improvements and immediate symptom relief,” said Dr. Toma. “We believe these 6-month follow-up data suggest that removal of clot burden without the risks of lytics has potential positive long-term implications for PE patients, including strikingly low rates of hospital readmissions, dyspnea, CTED, and CTEPH. These data suggest that treatment with FlowTriever may fundamentally improve the natural course of the disease, and that is tremendously exciting.”
“FlowTriever is quickly becoming the frontline therapy for intermediate and high-risk PE. FLASH, already the largest prospective interventional data set in the field of PE, reinforces the excellent safety, functional improvement, and long-term outcomes of this approach,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “We believe these data continue to raise the bar to which existing and new treatments will be held. We remain committed to venous thromboembolism patients and to advancing the treatment of this disease through clinical research and the continued development of purpose-built devices.”