Angiodynamics, Inc.
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.
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
Inclusion Criteria: A potential subject will be included in the study if he/she meets all the following inclusion criteria: 1. Provision of signed and dated informed consent form. 2. Subject is 18 years of age and older. 3. Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. 4. Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). 5. Subject has a RV/LV ratio of 0.9 or higher. 6. Subject has a systolic blood pressure (SBP) of 90mmHg or higher. 7. Subject has a h…
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.