The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
Provision of signed and dated informed consent form.
Subject is 18 years of age and older.
Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.
Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
Subjects who have used thrombolytics in the 30 days prior to the baseline CTA.
Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.