Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.
‣ Subjects must meet all following general inclusion criteria:
• Age ≥ 18 and ≤ 75 years.
• Clinical signs, symptoms, and presentation consistent with acute PE;
• PE symptom duration ≤ 14 days;
• 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;
• Stable heart rate \< 130 BPM prior to procedure;
• Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
• Informed Consent Form signed
⁃ Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit