Latham, New York, April 28, 2022 – 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 quality of life for patients, announced the launch of the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV), a new clinical study aimed at evaluating the efficacy and safety of their AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk pulmonary embolism (PE).
AngioDynamics initiated the APEX-AV study in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium™. The single-arm study will be led by co-Principal Investigators William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and President, The PERT Consortium™; and Mona Ranade, MD, Assistant Professor, Interventional Radiology, David Geffen School of Medicine at UCLA.
APEX-AV is a single-arm Investigational Device Exemption study that will enroll patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites in the United States. Patient enrollment is anticipated to commence in the summer of 2022. 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.
“Pulmonary embolism is estimated to affect one in every thousand people in the United States each year and can be life-threatening,”1 said Juan Carlos Serna, Senior Vice President, Scientific & Clinical Affairs, AngioDynamics. “Developing and assessing innovative, minimally invasive treatment options for PE is vitally important to AngioDynamics, our partners in The PERT Consortium™, and patients and providers. We are driven to continue innovating in this space, creating better treatment options, and advancing patient care through reliable and predictable outcomes. We are grateful for the leadership of Drs. Keeling and Ranade, and to The PERT Consortium™, for joining us in launching this critical research study.”
“The APEX-AV Study represents an important trial in the PE space,” said Dr. Keeling. “It will hopefully add to the growing body of literature substantiating catheter-based embolectomy as a safe and efficacious treatment for patients with intermediate-risk PE.”
“The APEX-AV study evaluates the safety and efficacy of the new AlphaVac F1885 system in intermediate-risk PE patients,” said Dr. Ranade. “Generating high-level data on PE treatment is of extreme importance. I am optimistic that the APEX-AV study will significantly contribute to the growing evidence in the treatment of PE, thereby advancing patient care.”
About the AlphaVac MMA F1885 PE System
The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is an off-the-shelf, easy to assemble, emergent first-line device that is safe for the removal of 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. Risk information: https://bit.ly/Angio-risk-info
The AlphaVac MMA F1885 PE System when used for treatment of pulmonary embolism is an investigational device. Limited by United States law to investigational use.
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 quality of life for patients.
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.
About The PERT Consortium™
The purpose of The PERT Consortium™ is to serve the general public by undertaking activities to advance the status of PE care and promote research in the treatment of pulmonary embolism. Specifically, the Consortium’s purpose is to:
Promote the adoption of the PERT model in healthcare institutions across the United States to ensure the prompt diagnosis and treatment of pulmonary embolism.
Expand the current body of scientific literature on the diagnosis and treatment of pulmonary embolism through the funding of scientific endeavors.
Educate the general public and healthcare professionals regarding pulmonary embolism diagnosis, treatment, and care.
By focusing solely on the entity of pulmonary embolism – its etiology, pathophysiology, prevention, management approach, outcomes of specific treatments, and follow-up pathways – it is the intention of the Consortium 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 impact of this terrible disease.
Investor Relations Contact:
1 Learn About Pulmonary Embolism. Lung.org. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism. Published 2020.