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 completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a clinical study aimed at evaluating the safety and efficacy of the Company’s AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of 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,” said Juan Carlos Serna, AngioDynamics’ Senior Vice President of Clinical and Scientific Affairs. “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 across 25 hospital-based sites in the United States. 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.
“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, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™.
AngioDynamics initiated the APEX-AV Study in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium™. The study is led by co-Principal Investigators 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™ and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.
“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,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.
Pulmonary embolism (PE) can be a life-threatening condition that affects around 900,000 people in the United States every year.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
Visit https://clinicaltrials.gov/ct2/show/NCT05318092 for more information about the APEX-AV Study.
The AlphaVac MMA F1885 System is an emergent first-line device that is currently cleared 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. The APEX-AV Study was designed to provide safety and efficacy data for a clearance specific to PE. For risk information.
The AlphaVac MMA F1885 System, when used for treatment of pulmonary embolism, is an investigational device, limited by United States law to investigational use.