FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism

Inclusion Criteria:

Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions

Exclusion Criteria:

• Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
• Witnessed cardiac arrest with ongoing CPR >30 minutes
• Contraindication to anticoagulants, i.e. heparin or alternative
• Hematocrit <28%
• Platelets <25,000/μL
• INR >8
• Intracardiac thrombus and/or intracardiac clot in transit
• Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
• History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg
• Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
• Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
• Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)