Safety and Effectiveness of the ATC System in the Treatment of Acute PE

Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 90 years old

2. Clinical signs and symptoms consistent with acute PE for < 14 days

3. CTA evidence of proximal PE

4. RV/LV ratio > 0.9

5. Systolic BP ≥90 mmHg without the need for vasopressors

6. Stable heart rate (HR) < 130 BPM prior to procedure

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

8. Subject or legally authorized representative (LAR) is willing and able to providewritten informed consent prior to receiving any non-standard of care protocolspecific procedures

Exclusion Criteria:

1. Prior PE < 180 days from index procedure

2. Thrombolytic use < 30 days prior to baseline CTA

3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHgby right heart catheterization

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

5. Hematocrit <28%

6. Platelets count <100,000/µL

7. Serum creatinine >1.8 mg/dL

8. International normalized ratio (INR) >3

9. Major trauma injury severity score (ISS) >15 prior to screening assessment

10. Presence of intracardiac lead in right ventricle or atrium placed within 6 monthsprior to screening assessment

11. Cardiovascular or pulmonary surgery within 7 days of index procedure

12. Actively progressing cancer treated by chemotherapeutics

13. Known bleeding diathesis or coagulation disorder

14. Left bundle branch block

15. History of severe or chronic pulmonary arterial hypertension

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

17. History of decompensated heart failure

18. History of underlying lung disease that is oxygen dependent

19. History of chest irradiation

20. History of heparin-induced thrombocytopenia (HIT)

21. Contraindication to systemic or therapeutic doses of anticoagulants

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

23. Imaging evidence or other evidence that suggest, in the opinion of the investigator,the Subject is not appropriate for aspiration thrombectomy intervention

24. Life expectancy <90 days, as determined by investigator such as stage 4 cancer,frailty or severe COVID infections

25. Female who is pregnant or nursing

26. Current participation in another investigational drug or device treatment study.