Evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Prospective, single-arm, multicenter study. Approximately 125 subjects will be screened for 105 enrolled at up to 15 investigational sites in the United States.
1. At least 18 years of age at the time of consent. 2. Clinical signs, symptoms, and presentation consistent with acute PE. 3. Onset of PE symptoms occurred within 14 days of presentation. 4. Filling defect in at least one main or lobar pulmonary artery evidenced by CTA. 5. RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9.
Principal Investigator