Evaluation of the Safety and Performance of Magneto PE Kit

Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism

This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.

Inclusion Criteria:

• Clinical signs, symptoms and presentation consistent with acute PE
• PE symptom duration ≤ 14 days
• CTA evidence of PE
• RV/LV ratio ≥ 0.9
• Heart rate <130 BPM prior to procedure
• Subject medically eligible for interventional procedure
• Age ≥ 18 and <75 years
• Consent process is completed

Exclusion Criteria:

• Thrombolytic use within 14 days
• Known bleeding diathesis or coagulation disorder
• Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
• Hemodynamic collapse at presentation
• Decompensated heart failure
• Presence of Extra-Corporeal Membrane Oxygenation.
• Major trauma ISS> 15 within 14 days
• Cardiovascular or pulmonary surgery within last 7 days
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• Hematocrit < 28%
• Platelets < 100,000/µL
• Serum creatinine > 1.8 mg/dL
• INR>2
• Left bundle branch block
• PAP > 70 mmHg m
• Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
• Presence of intracardiac lead in right ventricle or atrium.
• Pacemaker or Implantable Cardioverter Defibrillator
• Presence of intracardiac thrombus
• Anaphylactic reaction to radiographic contrast agents that cannot be pre-treated
• Known right- to-left shunt,
• Known left ventricular ejection fraction ≤ 30%
• History of severe chronic pulmonary arterial hypertension
• History of underlying lung disease with oxygen dependence
• History of chest irradiation
• History of Heparin Induced Thrombocytopenia (HIT)
• Female who is pregnant or nursing
• Current participation in another investigational drug or device treatment study
• Life expectancy of < 90 days as determined by the investigator
• Subjects who are intubated