AngioDynamics has initiated a comprehensive study to evaluate the efficacy and safety of the AlphaVac Mechanical Aspiration Thrombectomy System for treating acute, intermediate-risk pulmonary embolism (PE) in Europe.
The RECOVER-AV trial will recruit patients at multiple European hospital sites and assess the system’s ability to reduce the ratio of right ventricular (RV) to left ventricular (LV) volumes, a key indicator of heart function, within 48 hours of the procedure. The study will also monitor the incidence of adverse events related to the device or bleeding within seven days.
Building upon the positive results of the APEX-AV study in the United States, RECOVER-AV aims to further establish the AlphaVac F1885 System as a safe and effective treatment for intermediate-risk PE in Europe. With an estimated 435,000 PE events annually in the European Union, the prevalence of severe PE is higher in Europe compared to the United States.
The study will follow patients for 12 months, assessing their functional outcomes at 30 days, six months, and one year. This comprehensive monitoring will provide insights into the long-term benefits of the AlphaVac system.
The CE Mark approval of the AlphaVac F1885 System in Europe marks a significant milestone for AngioDynamics, allowing the company to expand its reach in a region with a substantial prevalence of PE. The company is committed to generating robust clinical evidence worldwide, demonstrating its dedication to improving patient care and treating vascular diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.