Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism

Inclusion Criteria:

• Age ≥ 18 years
• Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE)
• PE symptom duration ≤ 14 days
• Filling defect in at least one main or lobar pulmonary artery on CTA
• Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading)
• Systolic blood pressure ≥ 90 mmHg
• Stable heart rate < 130 BPM prior to the index procedure
• Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters
• Written informed consent

Exclusion Criteria:

• Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE)

• PE within 3 months prior to screening assessment

• Thrombolytic use within 30 days prior to baseline CTA

• Pulmonary hypertension with peak systolic PAP > 70 mmHg

• Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg

• Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90%

• Any of the following laboratory findings (within 6 hours prior to index procedure):

  1. Hematocrit < 28%
  2. Platelets < 100,000/µL
  3. Serum creatinine > 1.8 mg/dL
  4. INR > 3

• Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment

• Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment

• Known presence of intracardiac clot

• Cardiovascular or pulmonary surgery within last 7 days

• Active malignancy and / or on chemotherapy

• Known bleeding diathesis or coagulation disorder

• Left bundle branch block

• History of severe or chronic pulmonary arterial hypertension

• History of left ventricular ejection fraction ≤ 30%

• History of decompensated heart failure

• History of underlying oxygen dependent lung disease

• History of chest irradiation

• History of Heparin Induced Thrombocytopenia (HIT)

• Any contraindication to systemic therapeutic doses of heparin or other anticoagulants

• Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated

• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

• Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention

• Life expectancy of < 90 days as determined by the investigator

• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

• Female who is pregnant or nursing

• Current participation in another investigational drug or device treatment study

• Previous enrollment in the eTrieve™ II Study