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)

Exclusion Criteria28

• 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 chemotherapeutics
• 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 (HIT)
• Contraindication to systemic or therapeutic doses of anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
• CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
• Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
• Female who is pregnant or nursing
• Current participation in another investigational drug or device treatment study