AngioDynamics has announced the enrollment of the first patient in its RECOVER-AV clinical trial, marking a significant milestone in the company's efforts to expand global access to mechanical thrombectomy treatment for pulmonary embolism (PE). The prospective, multi-center, multi-national, single-arm study will evaluate the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in patients with acute, intermediate-risk pulmonary embolism.
The trial follows the United States Food and Drug Administration (FDA) 510(k) clearance of the AlphaVac F1885 System for PE treatment in April 2024 and its CE Mark approval in Europe in May 2024. The study is designed to evaluate the safety and efficacy of the device while assessing long-term functional outcomes for patients following treatment.
Clinical Trial Design and Scope
The RECOVER-AV trial will enroll patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites across Europe, Canada, and Hong Kong. The primary safety endpoint focuses on the incidence of adverse events by type and seriousness through 12 months of follow-up.
Patients will be monitored for 12 months, with functional and quality-of-life outcomes assessed at 30 days and 12 months. The comprehensive evaluation will include cardiac MRI and exercise testing to provide detailed assessment of long-term recovery following mechanical thrombectomy with the AlphaVac MMA F1885 System.
The trial is led by co-Principal Investigators Erik Klok, MD, Professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center, and Andrew Sharp, MD, Professor of Interventional Cardiology at Mater Misericordiae Hospital and University College Dublin.
"Pulmonary embolism continues to be a leading cause of morbidity and mortality across Europe, underscoring the need for treatment strategies that are both safe and effective," said Professor Klok. "We're pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients."
First Patient Procedure
Aleksander Araszkiewicz, MD, PhD, Assistant Professor at Poznan University of Medical Sciences in Poland, completed the first procedure as part of the trial. "Performing the first case in the RECOVER-AV study marks an important step forward in expanding treatment options for patients with intermediate-risk pulmonary embolism," said Prof. Araszkiewicz. "The AlphaVac F1885 System offers a promising mechanical thrombectomy solution, and I'm encouraged by its ease of use and the immediate clinical results we observed."
Market Context and Clinical Need
The prevalence of PE in Europe represents a significant healthcare burden, particularly among hospitalized and older populations. An estimated 435,000 PE events occur annually in the six largest European Union countries, highlighting the substantial clinical need for effective treatment options.
Laura Piccinini, Senior Vice President/General Manager, Cardiovascular and International at AngioDynamics, emphasized the strategic importance of the trial: "The first patient enrollment in the RECOVER-AV trial marks an important step forward as AngioDynamics continues to grow its global clinical presence and commitment to evidence-based care. With AlphaVac already 510(k)-cleared in the U.S. and CE-marked in Europe for PE, we're investing in high-quality data focused on functional recovery and quality of life that will equip clinicians, payers, and patients with even greater confidence in the system's safe, effective performance."
Building on Previous Evidence
The RECOVER-AV study builds on results from the company's U.S.-based APEX-AV trial, which demonstrated that the AlphaVac F1885 System is safe and effective for use in intermediate-risk PE patients. The previous trial showed significant improvements in right ventricular function and reduction in clot burden.
Device Technology
The AlphaVac F1885 System is designed as an emergent first-line device for the non-surgical removal of thromboemboli from the pulmonary arteries. The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. The device is positioned to support frontline treatment of PE and expand options for healthcare providers managing patients with life-threatening venous thromboembolism.
The RECOVER-AV trial represents a critical step in AngioDynamics' strategy to generate comprehensive evidence supporting the global adoption of mechanical thrombectomy treatment for intermediate-risk pulmonary embolism patients, potentially establishing new standards of care in this high-need therapeutic area.
