We Are Currently Enrolling in This Study.
The APEX-Return study is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA System for the treatment of acute pulmonary embolism.
Acute Pulmonary Embolism Treatment with the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)
APEX-Return is a prospective, multicenter, single-arm Investigational Device Exemption (IDE) Study that will enroll patients with confirmed acute, intermediate-risk PE. The APEX-Return Study will evaluate the safety and effectiveness of the AlphaReturn Blood Management system when used with the AlphaVac MMA system, to collect and filter the aspirated blood from the thrombectomy procedure prior to returning blood back to the patient.
The primary effectiveness endpoint of the APEX-Return Study is the successful autologous blood transfusion using the AlphaReturn Blood Management System.
The primary safety endpoint is the number and proportion of subjects who experienced at least one device-related adverse event.
Full study information can be found on ClinicalTrials.gov under identifier NCT07280247.
Risk Statement: Refer to instructions for Use and/or User Manual provided with the product for complete instructions, warnings, precautions, potential complications and contraindications prior to use of the product.
CAUTION: The use of the AlphaReturn Blood Management System with the AlphaVac MMA System to collect and filter the aspirated blood from the thrombectomy procedure, prior to returning to the blood back to the patient is an investigational device limited by United States law for investigational use only.
Federal law (USA) restricts this device to sale by or on the order of a physician.
AlphaVac and AlphaReturn are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. Copyright 2026 AngioDynamics, Inc.