Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

Inclusion Criteria: * Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA. * Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio \> 0.9 * Patient is 18 years of age or older Exclusion Criteria: * tPA use within 14 days prior to baseline CTA * Systolic BP \< 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg * Pulmonary hypertension with peak PA \> 70 mmHg by right heart catheterization * History of severe or chronic pulmonary hypertension * Fi02 requirement \> 40% or \>6 LPM to keep oxygen saturations \>90% * Hematocrit \< 28% * Platelets \< 100,000µL * Serum creatinine \> 1.8 mg/dL * INR \> 3 * aPTT (or PTT) \> 50 seconds on no anticoagulation * History of heparin-induced thrombocytopenia (HIT) * Contraindication to systemic or therapeutic doses of anticoagulants * Major trauma \< 14 days * Presence of intracardiac lead * Cardiovascular or pulmonary surgery within last 7 days * Cancer requiring active chemotherapy * Known serious, uncontrolled sensitivity to radiographic agents * Life expectancy \< 90 days * Female who is pregnant * Intracardiac Thrombus * Patients on ECMO * Current participation in another investigational study