Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

Inclusion Criteria: 1. Patient is \> 18 and \< 90 years old 2. Clinical signs and symptoms consistent with acute PE 3. PE symptom duration ≤ 14 days 4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator) 5. CTA evidence of RV/LV ratio \> 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline; 6. Systolic BP ≥ 90 mmHg note: initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation 7. Stable heart rate (HR) \< 130 BPM prior to procedure 8. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment. 9. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures Exclusion Criteria: 1. Prior PE \< 180 days from index procedure 2. Thrombolytic use \< 48 hours prior to baseline CTA 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization 4. Vasopressor requirement after fluids to keep pressure at ≥90 mmHg 5. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90% 6. Hematocrit \