Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)

Inclusion Criteria: * The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement * Clinical signs, symptoms and presentation consistent with acute PE * PE symptom duration ≤ 14 days * CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) * CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline) * Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation) * Stable HR \< 130 BPM prior to the procedure Exclusion Criteria: * Prior PE \<180 days from index procedure * Thrombolytic use within 30 days prior to baseline CTA * Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization * Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg * FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%) * Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure) * Platelets \< 100,000/μL * eGFR \<30 ml/min per 1.73 m2 * International normalized ratio (INR) \> 3 * Major trauma injury severity score (ISS) \> 15 * Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment * Cardiovascular or pulmonary surgery within the last 7 days * Actively progressing cancer treated by chemoth…