Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)
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.
⁃ A potential subject will be included in the study if he/she meets all the following inclusion criteria:
• 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).
• Subject has a RV/LV ratio of 0.9 or higher.
• Subject has a systolic blood pressure (SBP) of 90mmHg or higher.
• Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure.
• Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.