A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
⁃ Patients must meet ALL of the following criteria to be eligible for participation in the study:
• \*Patient is \> 18 and \< 90 years old
• \*Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator
• (\*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• (\*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)
• \*Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• \*Heart rate \< 130 BPM prior to procedure
• \*Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures