Inari Medical has announced the enrollment of the first high-risk pulmonary embolism (PE) patient in the FLAME (FlowTriever for acute massive pulmonary embolism) study. One in 20 PE diagnoses is categorized as high risk, and these are associated with a mortality rate of up to 40% at 90 days.
The first FLAME patient was enrolled at the Penn Presbyterian Hospital & Hospital of the University of Pennsylvania (HUP) in Philadelphia by co-principal investigators Sameer J. Khandhar, MD, and Jay S. Giri, MD.
“We are pleased to be the first site to enroll a patient in FLAME,” said Khandhar, of Penn Medicine. “We frequently see on-table normalization of hemodynamics using FlowTriever to extract large clots in PE patients. We are eager to formally study this effect in high-risk PE patients in whom the immediacy of this impact might reverse the death spiral and save lives,” he added.
FLAME is a prospective, multicenter, parallel-group observational study evaluating treatment outcomes for up to 250 high-risk PE patients. It is the largest ever high-risk PE study of any intervention, and its design—informed by evidence development guidance from the American Heart Association (AHA)—aims to change the high-risk PE treatment guidelines.
“Conservatively managed high-risk PE is associated with high mortality, but there are limited data supporting interventional treatment. We have designed FLAME to prospectively examine all patients at participating centers with high-risk PE, including those not treated with FlowTriever, to maximize generalizability of the study,” said Giri, of HUP.
Beyond FLAME, Inari continues to invest in its clinical study pipeline. Positive long-term late-breaking results were recently presented at VENOUS2021 (March 17–20, virtual), the annual meeting of the American Venous Forum, from both the CLOUT and FLASH studies. FLASH—already the largest prospective hemodynamic study of any PE treatment ever—is being doubled in size to 1,000 patients to collect data from a conservatively managed subgroup and include sites outside the U.S. In addition, for the first time ever, 200 patients will be monitored and studied using the Apple Watch.