October 19, 2020
FLASH Registry Evaluates Inari Medical’s FlowTriever for Thrombectomy in PE Patients
October 19, 2020—Inari Medical, Inc. announced interim results from the first 230 patients enrolled in its FLASH study from a real-world pulmonary embolism (PE) population, including high- and intermediate-risk patients enrolled at 19 sites in the United States.
FLASH is a 500-patient, prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of PE with the company’s FlowTriever thrombectomy device.
National Principal Investigator, Catalin Toma, MD, Director of Interventional Cardiology at UPMC Heart & Vascular Institute in Pittsburgh, Pennsylvania, presented the data at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
According to Inari, the findings showed that the primary endpoint of freedom from major adverse events at 48 hours was met by 227 (98.7%) of the first 230 patients enrolled in the study.
Additionally, all secondary outcome measures analyzed showed statistically significant and clinically meaningful improvements from baseline. Secondary endpoints included impact on acute hemodynamics, procedural measures, 48-hour all-cause mortality, and longer-term patient outcomes.
“FLASH represents the largest prospective hemodynamic study of any PE treatment ever undertaken and is the first major all-comers study of a purely mechanical thrombectomy approach to PE,” commented Dr. Toma in Inari’s announcement. “There were no deaths at 48-hour follow-up, no cardiac or pulmonary injuries, no procedure-related clinical deteriorations, and not a single instance of intracranial hemorrhage, a limitation of thrombolytic drugs.”
Dr. Toma continued, “Hemodynamic parameters including pulmonary artery pressures and cardiac index improved significantly postprocedure. These results were achieved in short single-session procedures. Additionally, by obviating the need for thrombolytic infusion, FlowTriever enabled patients to minimize stay in critically needed intensive care unit beds to a median duration of 0 days following intervention.”
Inari Medical stated that immediate postprocedure hemodynamic improvements have not been demonstrated with thrombolytic-based approaches, which can take several hours to take effect. By contrast, after clot removal with FlowTriever, patient heart rates quickly improved by an average of 23 beats per minute. The majority (77%) of patients were tachycardic (> 100 bpm) preprocedure versus 25% immediately after the procedure. Similarly, the average pulmonary artery pressure dropped 7 mm Hg, with several patients normalizing immediately after clot removal.