FlowTriever Pulmonary Embolectomy Clinical Study

Inclusion criteria

• Clinical signs, symptoms and presentation consistent with acute PE
• PE symptom duration ≤ 14 days
• CTA evidence of proximal PE
• RV/LV ratio ≥ 0.9 without syncope
• Systolic BP ≥ 90 mmHg
• Stable heart rate <130 BPM prior to procedure
• Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment

Exclusion criteria

• Thrombolytic use within 30 days of baseline CTA
• Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization
• Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• Hematocrit < 28% within 6 hours of index procedure
• Platelets < 100,000/µL
• Serum creatinine > 1.8 mg/dL
• INR > 3
• Major trauma ISS > 15
• Presence of intracardiac lead in right ventricle or atrium placed within 6 months
• Cardiovascular or pulmonary surgery within last 7 days
• Actively progressing cancer
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• History of severe or chronic pulmonary arterial hypertension
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• History of uncompensated heart failure
• History of underlying lung disease that is oxygen-dependent
• History of chest irradiation
• History of Heparin-induced thrombocytopenia
• Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention
• Life expectancy of < 90 days
• Female who is pregnant or nursing
• Current participation in another investigational drug or device treatment study