Akura Medical
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).
Inclusion Criteria: * 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 th…
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P