AngioDynamics, Inc. announced the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a clinical study aimed at evaluating the safety and efficacy of the Company's AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk pulmonary embolism (PE). PERT represents the third-leading cause of cardiovascular mortality in the United States.

APEX-AV is a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States. The primary efficacy endpoint of the APEX-AV Study is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of Major Adverse Events (MAEs), including device-related death and major bleeding within the first 48 hours.

Patients will be followed for 30 days post-index procedure. AngioDynamics initiated the APEX-AV Study in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium?. The study is led by co-Principal Investigators William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium?

and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. Pulmonary embolism (PE) can be a life-threatening condition that affects around 900,000 people in the United States every year.2 In most cases, PE is caused by blood clots in the legs, called deep vein thrombosis, that travel to the lungs.2 Patients with submassive or intermediate-risk PE account for 35% to 55% of hospitalized patients with PE and have a mortality rate of 3 to 14%.