AngioDynamics, Inc. has announced the commencement of the RECOVER-AV (Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and long term functional outcomes of percutaneous mechanical aspiration thrombectomy for Treatment of Acute Pulmonary Embolism) trial. This trial will evaluate the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for treating acute, intermediate-risk pulmonary embolism (PE) in the European market.
The RECOVER-AV trial is a multi-center, multi-national study that will enroll patients with confirmed acute, intermediate-risk PE across up to 20 hospital sites in Europe. The primary efficacy endpoint is the reduction of the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. The primary safety endpoint focuses on the incidence of Major Adverse Events (MAEs), such as device-related death or major bleeding within seven days. Patients will be followed for 12 months, with functional outcomes assessed at 30 days, six months, and 12 months.
The trial follows the Acute Pulmonary Extraction Trial with AlphaVac (APEX-AV) study, 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 APEX-AV study, completed in December 2023, demonstrated that the AlphaVac F1885 System is safe in patients with acute intermediate-risk PE and provides significant improvement in right ventricular function and reduction in clot burden.
Prevalence of Pulmonary Embolism
An estimated 435,000 PE events occur each year in the six largest European Union (EU) countries. Compared to the United States, the prevalence of PE is higher for those patients admitted to the emergency department in Europe, and European patients also had higher acuity and worse outcomes.
Leadership Insight
Laura Piccinini, AngioDynamics Senior Vice President and General Manager of Endovascular Therapies and International, stated, "We are excited to launch this important trial as we assess the performance of the AlphaVac F1885 System in patients with intermediate-risk pulmonary embolisms. With our clinical partners, we are demonstrating our continued commitment to generating robust clinical evidence across the world, with this being the first international study we have sponsored highlighting our commitment as a global leader to treat more patients and advance care."
AlphaVac F1885 System
The AlphaVac F1885 System recently received CE Mark approval in Europe for the non-surgical removal of thrombi or emboli from pulmonary arteries, including for treating PE. The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
The Study 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. They are supported by an internationally renowned Scientific Advisory Board featuring leading experts in pulmonary embolism (PE) and related fields.
