AngioDynamics, Inc. announced that results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) were presented at The Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions hosted in Long Beach, California on May 3, 2024. The APEX-AV trial showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 (p < 0.001)) and a Major Adverse Event (MAEs) rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure1 and a mean procedure time of 37.2 minutes.

The APEX-AV trial was initiated in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium? and was led by co-Principal Investigators William Brent Keeling, MD, and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. The primary efficacy endpoint of the APEX-AV trial was the reduction in RV/LV ratio between baseline and 48 hours post-procedure.

The primary safety endpoint was the rate of MAEs, including events such as major bleeding and serious device-related clinical deterioration, pulmonary vascular injury and cardiac injury within the first 48 hours. Patients were followed for 30 days post-index procedure.