Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Exclusion Criteria

• •May be pregnant as determined by a positive pregnancy test or who are breastfeeding.
• •Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
• •Has used thrombolytics (tPA) in the past 30 days of baseline CTA.
• •Has pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg.
• •Fraction of inspired oxygen (FiO2) requirement \>40% or \>6 liters per minute (LPM) to keep oxygen saturations \>90%
• •Hematocrit \<28% within 6 hours of the index procedure.
• •Platelets count \< 100,000/µL.
• •Serum creatinine \>1.8 mg/dL.
• •International Normalized Ratio (INR) \> 3
• •Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15.
• •Presence of cancer requiring active chemotherapy.
• •Known bleeding diathesis or coagulation disorder.
• •Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
• •History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.
• •Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
• •Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.
• •With left bundle branch block.
• •Has intracardiac lead in the right ventricle or atrium.
• •Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.
• •Has life expectancy \< 90 days.
• •Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
• •Participation in another investigational study