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

Inclusion Criteria

- Signed and dated informed consent form. - 18 years of age and older. - Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. - Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). - Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher. - Systolic blood pressure (SBP) of 90 mmHg or higher - Heart rate of 130 beats per minute (BPM) or less prior to the procedure. - Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.

Exclusion Criteria

Excluded from the study if he/she meets any of the following 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