Sam Brusco, Associate Editor04.04.24
AngioDynamics has earned U.S. Food and Drug Administration (FDA) clearance for its AlphaVac F1885 system to treat pulmonary embolism (PE).
The expanded FDA indication broadens the device’s application to non-surgical removal of thrombi or emboli from the venous vasculature. The new indication expands options for treatment for PE patients, lowering thrombus burden and improving right ventricular function.
In December 2023, AngioDynamics revealed it had completed enrollment in its Acute Pulmonary Embolism Extraction trial with the AlphaVac system (APEX-AV) study. The trial enrolled 122 patients with acute, intermediate-risk PE in 25 U.S. hospitals to assess AlphaVac F885’s use to treat PE.
The APEX-AV Study showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 (p < 0.001)) and a MAEs rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure.
The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
“FDA clearance marks a significant advancement in patient care and safety. This milestone underscores our commitment to merging physician-centric design with patient outcome-driven solutions,” said Juan Carlos Serna, AngioDynamics senior VP of scientific and clinical affairs. “In addition to meeting our primary endpoints, the trial also showed a meaningful, favorable reduction in clot burden, ultimately improving patient outcomes.”
Earlier this week, AngioDynamics announced it had entered a settlement agreement with BD to resolve all outstanding patent litigation with C.R. Bard, an affiliate of BD.
The expanded FDA indication broadens the device’s application to non-surgical removal of thrombi or emboli from the venous vasculature. The new indication expands options for treatment for PE patients, lowering thrombus burden and improving right ventricular function.
In December 2023, AngioDynamics revealed it had completed enrollment in its Acute Pulmonary Embolism Extraction trial with the AlphaVac system (APEX-AV) study. The trial enrolled 122 patients with acute, intermediate-risk PE in 25 U.S. hospitals to assess AlphaVac F885’s use to treat PE.
The APEX-AV Study showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 (p < 0.001)) and a MAEs rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure.
The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
“FDA clearance marks a significant advancement in patient care and safety. This milestone underscores our commitment to merging physician-centric design with patient outcome-driven solutions,” said Juan Carlos Serna, AngioDynamics senior VP of scientific and clinical affairs. “In addition to meeting our primary endpoints, the trial also showed a meaningful, favorable reduction in clot burden, ultimately improving patient outcomes.”
Earlier this week, AngioDynamics announced it had entered a settlement agreement with BD to resolve all outstanding patent litigation with C.R. Bard, an affiliate of BD.