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 anaphy…