AngioDynamics Receives CE Mark Approval for AlphaVac F18⁸⁵ System in Europe

Wednesday, May 22, 2024

AngioDynamics, a prominent medical technology firm specializing in vascular health enhancement, cancer treatment expansion, and patient well-being improvement, has recently announced the European CE Mark approval of the AlphaVac F1885 System.

This innovative system is designed for the non-surgical removal of thrombi or emboli from the pulmonary arteries and the treatment of pulmonary embolism (PE).

AngioDynamics Senior Vice President/General Manager, Endovascular Therapies and International, emphasized the significance of this approval for enhancing patient care and safety in the EU. With a higher prevalence of PE in Europe compared to the United States.

This approval expands the company's reach and offers innovative solutions to healthcare professionals treating PE patients on a global scale.

In Europe, an estimated 435,000 PE events occur annually across the six largest EU countries. The AlphaVac F1885 System's CE Mark broadens treatment options by providing a tool to reduce thrombus burden and enhance right ventricular function in PE patients.

AngioDynamics successfully completed patient enrollment in the United States-based Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study in December 2023. This single-arm Investigational Device Exemption study, involving 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites, assessed the AlphaVac F1885 System for PE treatment.

Results from the APEX-AV trial demonstrated promising outcomes, including a significant mean decrease in the RV/LV ratio and a low Major Adverse Event (MAE) rate. Additionally, there was a substantial reduction in clot burden post-procedure, with a mean procedure time of 37.2 minutes.

The AlphaVac F1885 System, an emergent first-line device, offers a comprehensive solution for PE treatment, comprising an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.

The APEX-AV Study was specifically designed to provide safety and efficacy data for PE treatment. For more information on risks associated with this system.