Study Begins for AngioDynamics’ AlphaVac F18⁸⁵ System

AngioDynamics Inc. has officially launched a multicenter, multi-national trial (RECOVER-AV) to evaluate its AlphaVac Multipurpose Mechanical Aspiration (MMA) F18⁸⁵ System in treating acute pulmonary embolism (PE).

The single-arm study will assess the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy in treating intermediate-risk PE with the company’s AlphaVac MMA F18⁸⁵ System. Results will support the product’s European commercialization.

“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,” said Laura Piccinini, AngioDynamics senior vice president and general manager of Endovascular Therapies and International. “With our clinical partners, we are demonstrating our commitment to generating robust clinical evidence across the world, with this being the first international study we have sponsored highlighting our commitment to treat more patients and advance care.” 

This study follows the Acute Pulmonary Extraction Trial with AlphaVac (APEX-AV) study, a single-arm Investigational Device Exemption trial that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 U.S. hospital-based sites to assess the AlphaVac F18⁸⁵ System for the treatment of PE. APEX-AV 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.
 
The RECOVER-AV study is a multi-center, multi-national trial enrolling patients with confirmed acute, intermediate-risk PE across up to 20 European hospitals. 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.
 
An estimated 435,000 PE events occur each year in the six largest European Union (EU) countries.¹ 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.²
 
In May, the company announced that its AlphaVac F1885 System received CE Mark approval in Europe for the non-surgical removal of thrombi or emboli from pulmonary arteries, including for treating PE. The AlphaVac F18⁸⁵ System is designed to enhance treatment options for healthcare professionals and improve outcomes for patients suffering from PE.
 
The Study is led by co-principal investigators Erik Klok, M.D., professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center; and Andrew Sharp, M.D., professor of Interventional Cardiology at Mater Misericordiae Hospital and  University College Dublin.
 
They pair is supported by an internationally renowned Scientific Advisory Board featuring experts in pulmonary embolism and related fields, including Prof. Menno Huisman (Leiden UMC, Netherlands), John Moriarty, M.D. (UCLA), Prof. Makis Avgerinos (University of Athens, Greece), Prof. Irene Lang (Medical University of Vienna, Austria), Julie Helms, M.D. (CHRU Strasbourg, France), and Sebastian Stefaniak, M.D., and Mateusz Puslecki, M.D. (PUMS, Poland).
 
The AlphaVac F18⁸⁵ System is an emergent first-line device that is currently CE marked for the non-surgical removal of thromboemboli from the pulmonary arteries and for PE treatment. Cleared by the U.S. Food and Drug Administration in April, the System features an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. 

About AngioDynamics Inc. develops solutions to restore healthy blood flow in the body’s vascular system. The company is headquartered in Latham, N.Y.

References
¹ Willich SN, Chuang LH, van Hout B, Gumbs P, Jimenez D, Kroep S, Bauersachs R, Monreal M, Agnelli G, Cohen A. Pulmonary embolism in Europe – Burden of illness in relationship to healthcare resource utilization and return to work. Thromb Res. 2018 Oct;170:181-191. 
² Germini F., Zarabi S., Eventov M., Turcotte M., Li M., de Wit K. Pulmonary embolism prevalence among emergency department cohorts: A systematic review and meta‐analysis by country of study. Journal of Thrombosis and Haemostasis. 2022 Dec; 19(1):173-185