Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
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)
• CTA evidence of RV/LV ratio \> 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline;
• Systolic BP ≥ 90 mmHg note: initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation
• Stable heart rate (HR) \< 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment.
• Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures