Sam Brusco, Associate Editor05.22.24
AngioDynamics has earned CE mark approval for its AlphaVac F1885 system, which non-surgically removes thrombi or emboli from pulmonary arteries. It also treats pulmonary embolism (PE).
The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
Last month, the F1885 system gained U.S. Food and Drug Administration (FDA) clearance to treat PE. In December 2023, the Latham, N.Y.-based company completed patient enrollment in its U.S.-based Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study. The single-arm investigational device exemption (IDE) study enrolled 122 patients with acute, intermediate-risk PE in 25 hospital-based sites to evaluate AlphaVac 1885 for treating PE.
According to company data on file, the APEX-AV trial showed an average 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 Major Adverse Event (MAE) rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% average reduction in clot burden from baseline to 48 hours post-procedure3 and a mean procedure time of 37.2 minutes.
About 435,000 PE events happen each year in the six largest European Union (EU) countries. Prevalance of PE is higher for patients admitted to the emergency department in Europe compared to the U.S.; European patients also showed higher acuity and worse outcomes.
“The CE mark represents a major step forward in enhancing patient care and safety for endovascular therapies in the EU, a market with a higher prevalence of PE when compared to the United States,” said Laura Piccinini, AngioDynamics senior VP/GM, Endovascular Therapies and International. “This designation allows us to broaden our reach and provide innovative solutions to more healthcare professionals treating patients diagnosed with PE—on an increasingly global scale.”
The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
Last month, the F1885 system gained U.S. Food and Drug Administration (FDA) clearance to treat PE. In December 2023, the Latham, N.Y.-based company completed patient enrollment in its U.S.-based Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study. The single-arm investigational device exemption (IDE) study enrolled 122 patients with acute, intermediate-risk PE in 25 hospital-based sites to evaluate AlphaVac 1885 for treating PE.
According to company data on file, the APEX-AV trial showed an average 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 Major Adverse Event (MAE) rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% average reduction in clot burden from baseline to 48 hours post-procedure3 and a mean procedure time of 37.2 minutes.
About 435,000 PE events happen each year in the six largest European Union (EU) countries. Prevalance of PE is higher for patients admitted to the emergency department in Europe compared to the U.S.; European patients also showed higher acuity and worse outcomes.
“The CE mark represents a major step forward in enhancing patient care and safety for endovascular therapies in the EU, a market with a higher prevalence of PE when compared to the United States,” said Laura Piccinini, AngioDynamics senior VP/GM, Endovascular Therapies and International. “This designation allows us to broaden our reach and provide innovative solutions to more healthcare professionals treating patients diagnosed with PE—on an increasingly global scale.”