AngioDynamics Announces Publication of APEX-AV Trial Results in JSCAI
Peer-reviewed data highlights successful clinical study with 35.5% clot burden reduction, validating the safety, efficacy, and efficiency of AlphaVac F1885 System in pulmonary embolism treatment.
AngioDynamics, Inc. (NASDAQ:ANGO), a leading and transformative 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, today announced the publication of the results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI). The article, "Novel Mechanical Aspiration Thrombectomy in Patients with Acute Pulmonary Embolism: Results from the Prospective APEX-AV Trial," was published December 27, 2024.
Pulmonary embolism (PE), a potentially life-threatening condition, affects approximately 900,000 individuals annually in the United States, with 10-30% of cases resulting in death within one month of diagnosis, according to the American Lung Association.1
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 results demonstrated the device as a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events.
The APEX-AV trial demonstrated a 35.5% reduction in clot burden (via the Modified Miller index score), comparing favorably to other mechanical aspiration devices on the market.2 The unique design features of the device, including its funnel tip, optional wireless navigation, and blood loss mitigation, contributed to clinically significant improvements in both safety and efficacy.
"Achieving publication in a respected, peer-reviewed journal underscores the strength and importance of the APEX-AV trial findings and their potential impact on patient outcomes," said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. "The inclusion of the AlphaVac F1885 System in JSCAI validates our commitment to advancing meaningful solutions for pulmonary embolism, a life-threatening condition affecting hundreds of thousands of people each year. This milestone caps a transformative year for the AlphaVac F1885 System, following its FDA clearance for PE thrombectomy and its spotlight at the SCAI Scientific Sessions. We are proud to deliver innovations that equip physicians with effective tools to improve care and save lives."
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, Associate Professor at the Emory School of Medicine in Atlanta, Georgia, and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. The trial results were initially presented at The Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions hosted in Long Beach, California in May.
"We are incredibly excited by the results of the APEX-AV trial, which demonstrate the safety and efficacy of the AlphaVac F1885 System in treating patients with pulmonary embolism," said 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™. "These outcomes are critical for PE patients, where timely and efficient intervention can greatly improve long-term health outcomes and reduce the risk of complications."
In December 2023, AngioDynamics announced the completion of patient enrollment in its APEX-AV trial, 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 to assess the AlphaVac F18⁸⁵ System for the treatment of PE. In April 2024, the United States Food and Drug Administration (FDA) cleared the AlphaVac F1885 System for the treatment of PE.
"The results from the APEX-AV trial demonstrate the significant impact of the AlphaVac F1885 technology in treating pulmonary embolism," said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. "We observed a significant reduction in clot burden pre- and post-treatment, and saw a notable improvement in pulmonary artery pressures, underscoring the efficacy of this innovative approach. The procedure was completed with remarkable efficiency, with a short procedure time, making it a promising option for patients in need of rapid and effective intervention."
The published article concluded that "Percutaneous mechanical aspiration thrombectomy with the AlphaVac system provided a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events."
JSCAI publishes original research, comprehensive reviews, meta-analyses, study designs, society guidelines, editorials, research letters, case reports, and images. The subject matter includes all interventional subspecialities including coronary, peripheral, structural, and congenital heart disease.
To access the published material, visit: https://www.sciencedirect.com/science/article/pii/S2772930324021525.
About the AlphaVac F1885 System
The AlphaVac F1885 System is an emergent first-line device that is currently cleared for the removal of thromboemboli from the venous system and for the treatment of 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. For risk information, visit https://bit.ly/Angio-risk-info.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative 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 innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics' expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as "expects," "reaffirms," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "projects," "optimistic," or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics' expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics' technology or assertions that AngioDynamics' technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics' SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo and AlphaVac are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.
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1 https://ihpi.umich.edu/news/pulmonary-embolism-deaths-disparities-high-despite-advancements-care
2 https://www.sciencedirect.com/science/article/pii/S2772930324021525
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