AngioDynamics announced that it launched a new trial evaluating its AlphaVac F18 system in treating pulmonary embolism (PE).
The prospective, multicenter, multi-national, single-arm trial evaluates the AlphaVac F18 multipurpose mechanical aspiration system. It looks at the efficacy, safety and long-term functional outcomes of using it to perform percutaneous mechanical aspiration thrombectomy.
RECOVER-AV aims to evaluate the system in acute, intermediate-risk PE to support its adoption in the European market. AlphaVac F18 received CE mark approval in May of this year, just over a month after it picked up FDA approval.
The trial follows an FDA investigational device exemption study that enrolled 122 patients across 25 U.S. sites. RECOVER-AV will take place across 20 sites in Europe with a primary efficacy endpoint of reducing right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. Its safety endpoint focuses on the incidence of Major Adverse Events (MAEs). Those include device-related death or major bleeding within seven days.