AngioDynamics Shares Positive Study Results for AlphaVac System

AngioDynamics Inc. is touting promising study results showing its AlphaVac System helps reduce blood clots and improves right ventricular function in patients suffering from a pulmonary embolism.

The Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) showed a mean decrease in the right ventricular to left ventricular (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 4.1% major adverse event (MAEs) rate (significantly lower than the 25% pre-defined performance goal [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.¹
 
“The impressive reduction in clot burden, in addition to the safety and efficacy results observed in the APEX-AV trial, underscore the importance of integrating this technology into the treatment of acute PE,” said William Brent Keeling, M.D., associate professor of Surgery, Department of Surgery, at the Emory University School of Medicine, immediate past president of The PERT Consortium, and co-principal APEX-AV study investigator. “Pulmonary emboli can be extremely dangerous and require effective and prompt action.” 
 
Pulmonary embolism (PE) affects approximately 900,000 people in the United States annually and is the third leading cause of cardiovascular mortality in the nation.^2,3 Patients with sub-massive or intermediate-risk PE account for 35% to 55% of hospitalized patients with PE and have a mortality rate of 3% to 14%.^3,4
 
In December 2023, AngioDynamics completed patient enrollment in its APEX-AV trial, a single-arm U.S. Food and Drug Administration (FDA) Investigational Device Exemption study that enrolled 122 subjects with confirmed acute, intermediate-risk PE at 25 U.S. hospitals to assess the AlphaVac F18⁸⁵ System for PE treatment. The FDA cleared the AlphaVac F18⁸⁵ System in April.
 
“The results of the trial highlight the unique features of the AlphaVac device,” stated Juan Carlos Serna, AngioDynamics senior vice president of Scientific and Clinical Affairs. “The reduction in clot burden of 35.5% compares favorably to the 9.3% reduction reported in the current market leader’s IDE data. The mean procedure time was 37 minutes compared to 57 minutes as reported by the current market leader. These results were achieved while maintaining a clinically equivalent primary efficacy and safety comparison.”^1,5,6
 
The APEX-AV trial was initiated in partnership with the Pulmonary Embolism Response Team (PERT) Consortium and was led by co-principal investigators Keeling and Mona Ranade, M.D., assistant professor of Interventional Radiology, at the David Geffen School of Medicine at UCLA.
 
“After demonstrating safety and effectiveness in patients, the FDA clearance of AlphaVac 18⁸⁵ System for PE thrombectomy marks a significant milestone in interventional medicine,” Ranade commented. “The system’s overall ease of use with its steerable cannula and ability to navigate without a wire between the pulmonary arteries promises to enhance patient outcomes by providing a minimally invasive solution to a critical medical challenge and demonstrates a commitment to advancing cardiovascular care.”
 
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.
 
The AlphaVac F18⁸⁵ System is an emergent first-line device currently cleared for the removal of thromboemboli from the venous system and for treating PE. 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 Society for Cardiovascular Angiography & Interventions (SCAI) is a nonprofit medical society representing invasive and interventional cardiology. Founded in 1978, SCAI’s mission is to lead the global interventional cardiovascular community through education, advocacy, research, and quality patient care.
 
The PERT Consortium undertakes activities to advance the status of PE care and promote PE treatment research. Specifically, the Consortium’s purpose is to: promote the 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 through the funding of scientific endeavors; and educate the general public and healthcare professionals regarding PE diagnosis, treatment, and care. The Consortium aims to increase awareness of treatment options available to patients with PE, to reduce its incidence worldwide, to improve health outcomes, and to 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 firm is based in Latham, N.Y. 

References
¹ Data on file.
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 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.
⁴ 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.
⁵ The comparisons reported here are from two separate trials and not a head to head comparison. The FLARE trial (FlowTriever Pulmonary Embolectomy Clinical Study) was a prospective, single-arm, multicenter investigational device exemption trial in which patients with acute intermediate-risk PE were treated with the FlowTriever Retrieval/Aspiration System (Inari Medical, Irvine, California).
⁶ Tu T, Toma C, Tapson VF, Adams C, Jaber WA, Silver M, Khandhar S, Amin R, Weinberg M, Engelhardt T, Hunter M, Holmes D, Hoots G, Hamdalla H, Maholic RL, Lilly SM, Ouriel K, Rosenfield K; FLARE Investigators. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv. 2019 May 13;12(9):859-869.