FlowTriever2 Pulmonary Embolectomy Clinical Study

Inclusion Criteria:

• Clinical signs and symptoms consistent with acute PE

• PE symptom duration ≤ 14 days

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

• RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based onInvestigator's interpretation of RV/LV ratio)

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

• Stable heart rate < 130 BPM prior to procedure

• Patient is deemed medically eligible for interventional procedure(s), perinstitutional guidelines and/or clinical judgment.

• FlowTriever2 Catheter enters the vasculature

Exclusion Criteria:

• Thrombolytic use within 30 days of baseline CTA

• Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heartcatheterization

• Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg

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

• Hematocrit < 28% (NOTE: hematocrit required within 6 hours of index procedure)

• Platelets < 100,000/μL

• Serum creatinine > 1.8 mg/dL

• INR > 3

• Major trauma Injury Severity Score (ISS) > 15

• Presence of intracardiac lead in the right ventricle or right atrium placed within 6months

• Cardiovascular or pulmonary surgery within last 7 days

• Actively progressing cancer

• Known bleeding diathesis or coagulation disorder

• Left bundle branch block

• History of severe or chronic pulmonary arterial hypertension

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

• History of uncompensated heart failure

• History of underlying lung disease that is oxygen dependent

• History of chest irradiation

• History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemicor therapeutic doses heparin or anticoagulants

• Known anaphylactic reaction to radiographic contrast agents that cannot bepretreated

• 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)

• Life expectancy of < 90 days, as determined by Investigator

• Female who is pregnant or nursing

• Current participation in another investigational drug or device treatment study