FlowTriever Pulmonary Embolectomy Clinical Study

Inclusion Criteria:

- Clinical signs, symptoms and presentation consistent with acute PE

- PE symptom duration ≤ 14 days

- CTA evidence of proximal PE

- RV/LV ratio ≥ 0.9 without syncope

- Systolic BP ≥ 90 mmHg

- Stable heart rate <130 BPM prior to procedure

- Patient deemed medically eligible for interventional procedure(s), per institutional
guidelines and/or clinical judgment

Exclusion Criteria:

- Thrombolytic use within 30 days of baseline CTA

- Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterizatoin

- Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg

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

- Hematocrit < 28% within 6 hours of index procedure

- Platelets < 100,000/µL

- Serum creatinine > 1.8 mg/dL

- INR > 3

- Major trauma ISS > 15

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

- 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 HIT

- Any contraindication to systemic or therapeutic doses of heparin or anticoagulants

- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated

- Imaging evidence or other evidence that suggests the subject is not appropriate for
mechanical thrombectomy intervention

- Life expectancy of < 90 days

- Female who is pregnant or nursing

- Current participation in another investigational drug or device treatment study