Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
• The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
• Clinical signs, symptoms and presentation consistent with acute PE
• PE symptom duration ≤ 14 days
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
• Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
• Stable HR \< 130 BPM prior to the procedure