Endovascular Engineering ENGULF Study

Asterisks * indicate entry criteria that can be evaluated during prescreening without obtaining informed consent as they are part of standard of care PE management. Asterisks in parenthesis (*) indicate entry criteria that can be evaluated during prescreening without obtaining informed consent at Sites that routinely perform CTA as part of standard of care in PE management.

Inclusion Criteria:

Patients must meet ALL of the following criteria to be eligible for participation in the study:

1. *Patient is > 18 and < 90 years old

2. *Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14days, as determined by the Investigator

3. (*)CTA evidence of proximal PE (filling defect in at least one main or lobarpulmonary artery)

4. (*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator'sinterpretation of RV/LV ratio at baseline)

5. *Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressurerecovers to ≥ 90 mmHg with fluids)

6. *Heart rate < 130 BPM prior to procedure

7. *Patient is deemed medically eligible for interventional procedure(s), perinvestigator guidelines and clinical judgment

8. Patient signs a written Informed Consent form to participate in the study, prior toany study mandated procedures

Exclusion Criteria:

Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:

1. *Acute massive PE at presentation

2. *Prior PE within last 6 months

3. *Thrombolytic use within 30 days of baseline CTA

4. *Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg byright heart catheterization

5. *Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg

6. *FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%

7. *Hematocrit < 28% (NOTE: hematocrit required within 24 hours of index procedure)

8. *Platelets < 100,000/μL

9. *Serum creatinine > 1.8 mg/dL

10. *International normalized ratio (INR) > 3

11. *aPTT (or PTT) > 50 seconds on no anticoagulation

12. *Major trauma < 14 days

13. *Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months

14. *Cardiovascular or pulmonary surgery within last 7 days

15. *Life expectancy less than 1 year due to advanced malignancy, as determined by theinvestigator at the time of enrollment

16. *Known bleeding diathesis or coagulation disorder

17. *Known left bundle branch block

18. *History of severe pulmonary arterial hypertension

19. *History of chronic left heart disease with left ventricular ejection fraction ≤ 30%

20. *History of uncompensated heart failure

21. *History of underlying lung disease that is oxygen dependent

22. *Presence of IVC filter and or iliocaval stents

23. *History of heparin-induced thrombocytopenia (HIT)

24. *Any contraindication to systemic or therapeutic doses of heparin or anticoagulants

25. *Known anaphylactic reaction to radiographic contrast agents that cannot bepretreated

26. *Known allergy to any device component

27. (*)Imaging evidence or other evidence that suggests, in the opinion of theInvestigator, the Subject is not appropriate for mechanical thrombectomyintervention (e.g., inability to navigate to target location, predominately chronicclot or non-clot embolus)

28. *Life expectancy of < 90 days, as determined by Investigator

29. *Female who is pregnant or nursing

30. *Current participation in another investigational drug or device treatment study