This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
Patient is > 18 and < 90 years old
Clinical signs and symptoms 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 as determined by the investigator)
Prior PE < 180 days from index procedure
Thrombolytic use < 48 hours prior to baseline CTA
Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
Vasopressor requirement after fluids to keep pressure at ≥90 mmHg