Treating Pulmonary Embolism with Laguna Thrombectomy System (TRUST)

Inclusion Criteria:

1. ≥ 18 years of age; < 85 years old

2. RV/LV ratio > 0.9 as determined by CTA

3. Systolic blood pressure > 90 mmHg

4. Heart rate ≤ 120

5. Patient is deemed eligible for procedure by the interventional investigator

6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonaryartery)

7. PE Symptom duration ≤ 14 days

Exclusion Criteria:

1. Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamicassessments

2. Life expectancy of < 90 days in the opinion of investigator at the time ofenrollment

3. Subject pregnant or breast feeding

4. Current participation in another drug or medical device treatment study

5. In active chemotherapy or radiation treatment for a malignancy during the course ofthe study

6. Any intravascular administration of a fibrinolytic agent (such as Alteplase orTenecteplase) within the last 30 days

7. Presence of recently placed (<8 weeks) intracardiac devices (such as pacemakerleads) in the right ventricle or right atrium

8. History of prior PE within the past 90 days

9. FiO2 Requirement: > 40% (6 LPM) to keep oxygen saturation > 90%

10. Hematocrit: < 28%

11. Platelets: < 100,000/microliter

12. Serum Creatinine: > 2 mg/dL

13. International Normalized Ratio (INR): > 3

14. Major Trauma Injury Severity Score (ISS): > 15

15. Cardiovascular or pulmonary surgery within the last 7 days

16. Known bleeding diathesis or coagulation disorder that cannot be managed withanti-coagulation

17. History of known severe or chronic pulmonary arterial hypertension

18. History or chronic left heart disease with left ventricular ejection fraction < 30%

19. History of underlying lung disease that is oxygen dependent

20. History of chest irradiation

21. Known anaphylactic reaction to radiographic contrast agents that cannot bepretreated

22. Any absolute contraindication to systemic or therapeutic dosage of heparin oranticoagulants

23. Imaging or other evidence that suggests, in the opinion of the investigator, thesubject is not appropriate for mechanical thrombectomy intervention (e.g., inabilityto navigate to target location, predominantly chronic clot or non-clot embolus)

24. Known presence of clot in transit within right atrium or ventricle