Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Inclusion Criteria:

1. Clinical signs and symptoms consistent with acute PE with duration of 14 days orless

2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) orechocardiogram

3. Frontline endovascular treatment with the Indigo Aspiration System per IFU

4. Patient is ≥ 18 years of age

5. Informed consent obtained per Institutional Review Board/Ethics Committeerequirements

Exclusion Criteria:

1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)

2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery inthe affected lung(s) or chest radiation

3. Known serious, uncontrolled sensitivity to radiographic agents

4. Life expectancy < 180 days

5. Patients on ECMO

6. Pregnant patients

7. Current participation in another investigational drug or device study that mayconfound the results of this study. Studies requiring extended follow-up forproducts that were investigational but have since become commercially available arenot considered investigational studies

8. Other medical, social, or psychological conditions that, in the opinion of theInvestigator, precludes the patient from appropriate consent, could limit thepatient's ability to participate in the study, including compliance with follow-uprequirements, or that could impact the scientific integrity of the study