AngioDynamics begins trial with initial patient in the RECOVER-AV study
The RECOVER-AV clinical trial, a significant step forward in the treatment of intermediate-risk pulmonary embolism (PE), has recently commenced with the enrollment of its first patient. This prospective, multicentre, multinational study, launched in mid-2025, is designed to evaluate the safety and efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F18 85 system in the treatment of acute, intermediate-risk PE.
The RECOVER-AV trial is led by co-Principal Investigators Erik Klok and Andrew Sharp, with the goal of potentially influencing future standards of care for intermediate-risk PE patients. The trial aims to support the global adoption of the AlphaVac F18 85 system by generating high-quality evidence on its functional recovery and quality-of-life benefits for patients following mechanical thrombectomy treatment.
Patients will be followed for 12 months, with assessments of safety endpoints such as adverse event incidence and efficacy endpoints including functional outcomes and quality of life at 30 days and 12 months after treatment. Additional investigations, including Cardiac MRI and exercise testing, will provide a detailed view of long-term recovery.
The AlphaVac F18 system, which received U.S. FDA 510(k) clearance in April 2024 and CE Mark approval in Europe in May 2024, features an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly, designed for non-surgical removal of thromboemboli from pulmonary arteries.
The trial is enrolling patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites in Europe, Canada, and Hong Kong. Prof. Aleksander Araszkiewicz, MD, PhD, completed the first procedure of the RECOVER-AV study.
The RECOVER-AV trial builds on the results of the APEX-AV trial, where the AlphaVac system demonstrated its safety and efficacy, showing significant improvements in right ventricular function and reduction in clot burden. The primary safety endpoint for the trial is the incidence of adverse events by type and seriousness through 12 months.
The AlphaVac F18 System is designed to support frontline treatment of pulmonary embolism and expand options for healthcare providers managing patients with life-threatening venous thromboembolism. The prevalence of PE in Europe is significant, particularly among hospitalized and older populations, with an estimated 435,000 PE events occurring annually in the six largest European Union (EU) countries.
As the RECOVER-AV trial progresses, it represents an important step in validating the AlphaVac F18 85 system’s role in improving treatment and recovery for intermediate-risk PE patients globally. Definitive results and outcomes are still forthcoming, but the initial enrollment marks a promising start in expanding treatment options for those affected by this potentially life-threatening condition.
- The ongoing RECOVER-AV clinical trial is not only significant for the treatment of intermediate-risk pulmonary embolism (PE) but also for the medical-conditions related to cardiovascular-health, as it aims to evaluate the safety and efficacy of the AlphaVac F18 85 system, a medical device designed for non-surgical removal of thromboemboli.
- The RECOVER-AV trial is part of the science-driven approach to healthcare, with a focus on health-and-wellness, as it aims to generate high-quality evidence on the functional recovery and quality-of-life benefits of the AlphaVac F18 85 system for patients undergoing mechanical thrombectomy treatment.
- The RECOVER-AV trial, if successful, could potentially influence future standards of care for intermediate-risk PE patients worldwide, especially in regions with a significant prevalence of PE, such as Europe, contributing to improved cardiovascular-health and overall medical-conditions management.
