Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

AngioDynamics touts positive data from AlphaVac trial

AngioDynamics has unveiled data showing the safety and efficacy of its AlphaVac F1885 System in patients with acute intermediate-risk pulmonary embolism (PE), demonstrating significant improvements in right ventricular function and clot burden reduction.

 Results from the APEX-AV trial displayed a notable decrease of 0.45 in the RV/LV ratio at 48 hours, exceeding the expected improvement of 0.12. Major adverse events were observed in only 4.1% of cases, notably lower than the anticipated rate of 25%. Additionally, there was an average 35.5% reduction in clot burden post-procedure.

 The trial, concluding patient enrollment in December 2023, involved 122 patients across 25 US hospital-based sites, conducted in collaboration with the Pulmonary Embolism Response Team (PERT) Consortium.

 The AlphaVac MMA F1885 System, an innovative first-line device cleared by the US Food and Drug Administration (FDA) to address PE, features an ergonomic design and received clearance following the successful attainment of primary and secondary endpoints in the APEX-AV trial.