Enrollment Completed in AngioDynamics’ APEX-AV Study

AngioDynamics Inc. has completed patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV), a clinical study aimed at evaluating the safety and efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in treating acute intermediate-risk pulmonary embolism (PE).
 
PE represents the third-leading cause of cardiovascular mortality in the United States.¹
 
“The completion of the APEX-AV Study to assess the performance of the AlphaVac F1885 System in reducing thrombus burden and improving right ventricular function is a meaningful step toward expanding treatment options and improving care for patients with pulmonary embolism,” AngioDynamics’ Senior Vice President of Clinical and Scientific Affairs Juan Carlos Serna said. “We thank The PERT Consortium, including our enrolling partners, for its commitment to generating robust clinical evidence to help address the needs of this patient population.”
 
APEX-AV is a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE at 25 U.S. hospital-based sites. The primary efficacy endpoint of the APEX-AV Study is reducing 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.
 
“The completion of the APEX-AV Study represents an important milestone in the catheter-directed therapies CDT space for the treatment of pulmonary embolism. I sincerely thank all the investigators for their commitment and dedication,” said William Brent Keeling, M.D., associate professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate past president of The PERT (Pulmonary Embolism Response Team) Consortium, which partnered with AngioDynamics on the study. Keeling and Mona Ranade, M.D., assistant professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA, are co-principal study investigators.
 
“Data from the APEX-AV study expands the current body of literature on the safety and efficacy of mechanical thrombectomy and broadens the PE treatment options, particularly in this space,” Ranade stated.
 
Pulmonary embolism can be a life-threatening condition that affects around 900,000 people in the United States annually.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%.^1,3
 
The AlphaVac MMA F1885 System is an emergent first-line device that is currently cleared for removing thromboemboli from the venous system. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. The APEX-AV Study was designed to provide safety and efficacy data for a clearance specific to PE. The AlphaVac MMA F1885 System, when used to treat a pulmonary embolism, is an investigational device, limited by United States law to investigational use.
 
The PERT Consortium serves the general public by undertaking activities to advance PE care and promote research PE treatment. Specifically, the Consortium’s purpose is to: promote adoption of the PERT model in U.S. healthcare institutions to ensure prompt PE diagnosis and treatment; expand the current body of scientific literature on PE diagnosis and treatment; and educate the general public and healthcare professionals regarding PE diagnosis, treatment, and care. By focusing solely on the entity of PE—its etiology, pathophysiology, prevention, management approach, treatment outcomes, and follow-up pathways—the Consortium aims to increase awareness of treatment options available to PE patients, reduce its incidence worldwide, improve health outcomes, and positively influence the disease’s impact.
 
AngioDynamics is a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving patient quality of life. The company’s technologies and devices are chosen by physicians in fast-growing healthcare markets to treat unmet patient needs. 

References
¹ Giri J, Sista AK, Weinberg I, et al. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles For The Development Of Novel Evidence: A Scientific Statement From The American Heart Association. Circulation 2019;140(20)e774-e801.
² Learn About Pulmonary Embolism. Lung.org. http://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism. Published 2023.
³ Machanahalli Balakrishna A, Reddi V, Belford PM, Alvarez M, Jaber WA, Zhao DX, Vallabhajosyula S. Intermediate-Risk Pulmonary Embolism: A Review of Contemporary Diagnosis, Risk Stratification and Management. Medicina (Kaunas). 2022 Aug 30;58(9):1186.