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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Hep…