FLASH results demonstrate ‘excellent safety profile’ of the FlowTriever system in full US cohort

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Catalin Toma

Results of the FLASH registry demonstrate the “excellent safety profile” of the FlowTriever system (Inari Medical) in 800 real-world patients.

This is according to Catalin Toma, MD, from the University of Pittsburgh Medical Center, Pittsburgh, who presented outcomes for the full U.S. cohort of FLASH at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT; Sept. 16–19) in Boston. 

The results were simultaneously published in EuroIntervention. Toma reported a 1.4% major bleeding rate and 0.4% rate of other major adverse events (MAEs) in what the presenter described as the largest prospective interventional study in pulmonary embolism (PE).

All-cause mortality was <1% at the 30-day visit in this real-world population with prevalent baseline predictors of mortality, the presenter added, noting also that hemodynamics improved on-table, acute vitals and right ventricular (RV) strain normalized, and clinical recovery continued through six months.

The presenter noted that acute all-cause mortality following PE has remained high (>10%) over two decades. 

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