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
Single group
ATC System
DeviceThe ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
Effectiveness
Change in RV/LV ratio post index procedure
Safety: Composite of Major Adverse Device-Related Events
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
Safety: Composite of Major Adverse Events
Assessment of major adverse events through 30 day follow-up
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