APEX-AV trial results of AlphaVac PE system published in JSCAI

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AngioDynamics has 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 primary efficacy endpoint of the APEX-AV trial was the reduction in right ventricle to left ventricle (RV/LV) ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of major adverse events (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 favourably to other mechanical aspiration devices on the market. 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 US Food and Drug Administration (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, associate professor at the Emory School of Medicine (Atlanta, USA), and Mona Ranade, assistant professor, interventional radiology, at the David Geffen School of Medicine at University of California, Los Angeles (UCLA, Los Angeles, USA). The trial results were initially presented at The Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions (2–4 May, Long Beach, USA).

“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 Keeling. “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 enrolment in its APEX-AV trial, a single-arm investigational device exemption (IDE) study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the USA to assess the AlphaVac F18⁸⁵ System for the treatment of PE. In April 2024, the 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, 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: “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.”


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