Nasdaq-listed AngioDynamics has received the CE Mark approval in Europe for the AlphaVac F1885 System to treat pulmonary embolism (PE).
The American medical technology company has designed the AlphaVac F1885 System for the non-surgical removal of thrombi or emboli from the pulmonary arteries.
The system consists of an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
The CE Mark certification expands the scope of treatment options available to healthcare professionals across the European Union.
According to the medical technology company, the tool aids in reducing thrombus burden and enhancing right ventricular function in patients diagnosed with pulmonary embolism.
AngioDynamics senior vice president and endovascular therapies and international general manager Laura Piccinini said: “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.
“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.”
Last December, AngioDynamics concluded patient recruitment in its US-based Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study.
The single-arm investigational device exemption study registered 122 patients diagnosed with acute, intermediate-risk pulmonary embolism.
The patients were recruited across 25 hospital-based sites to evaluate the effectiveness of the AlphaVac F18⁸⁵ System in treating the condition.
As per the findings, the APEX-AV trial demonstrated a mean decrease in the right ventricle (RV)/ left ventricle (LV) ratio from baseline to 48 hours post-procedure, with a reduction of 0.45.
Additionally, the study displayed a major adverse event (MAE) rate of 4.1%, which was lower than the predefined performance goal of 25%.
Furthermore, the APEX-AV trial revealed a mean reduction in clot burden of 35.5% from baseline to 48 hours post-procedure, along with an average procedure time of 37.2 minutes.
Last month, AngioDynamics received the US Food and Drug Administration (FDA) 510(k) clearance for AlphaVac F18⁸⁵ System for the same indication.
