Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
• Age ≥ 18 years \< 80 years
• Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
• CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined).
• Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• Subject or subject's legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care Protocol-specific procedures
• Subject is willing and able to comply with all Protocol-required follow-up visits