Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

Inclusion Criteria:

1. Patient is > 18 and < 90 years old

2. Clinical signs and symptoms consistent with acute PE

3. PE symptom duration ≤ 14 days

4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonaryartery as determined by the investigator)

5. CTA evidence of RV/LV ratio > 0.9 note: based on Investigator's interpretation ofRV/LV ratio at baseline;

6. Systolic BP ≥ 90 mmHg note: initial SBP may be < 90 mmHg but ≥ 80 mmHg if thepressure recovers with volume resuscitation

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

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

9. 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 < 48 hours prior to baseline CTA

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

4. Vasopressor requirement after fluids to keep pressure at ≥90 mmHg

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

6. Hematocrit <28% (Note: hematocrit required within 6 hrs. of index procedure)

7. Platelets count <100,000/µL

8. eGFR <30 ml/min per 1.73 m2

9. International normalized ratio (INR) >3

10. Major trauma injury severity score (ISS) > 15

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

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

13. Actively progressing cancer treated by chemotherapeutics

14. Known bleeding diathesis or coagulation disorder

15. Left bundle branch block

16. History of severe or chronic pulmonary arterial hypertension

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

18. History of decompensated heart failure

19. History of underlying lung disease that is oxygen dependent

20. History of chest irradiation

21. History of heparin-induced thrombocytopenia (HIT)

22. Contraindication to systemic or therapeutic doses of anticoagulants

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

24. Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot orclot in transit (right atrium and/or right ventricle).

25. CTA imaging or other evidence that suggest, in the opinion of the investigator, theSubject is not appropriate for aspiration thrombectomy intervention (e.g., inabilityto navigate to target location, predominantly chronic clot or non-clot embolus)

26. Life expectancy <90 days, as determined by investigator

27. Female who is pregnant or nursing

28. Current participation in another investigational drug or device treatment studyNote: observational or registry studies may be permitted with Sponsor approval