AngioDynamics AlphaVac F18⁸⁵ System Approved in Europe

May 21, 2024—AngioDynamics, Inc. announced European CE Mark approval of the AlphaVac F18⁸⁵ system for the nonsurgical removal of thrombi or emboli from the pulmonary arteries and for the treatment of pulmonary embolism (PE).

According to the company, AlphaVac F18⁸⁵ helps reduce thrombus burden and improve right ventricular function in patients with PE. The system includes an ergonomic handle, an 18-F cannula with an 85º angle, an obturator, and a waste bag assembly.

As noted in the press release, AngioDynamics announced completion of patient enrollment in the United States–based APEX-AV trial in December 2023. The single-arm investigational device exemption study enrolled 122 patients with confirmed acute, intermediate-risk PE at 25 hospital-based sites to assess the AlphaVac F18⁸⁵ system for treatment of PE.

The company stated that the APEX-AV trial showed a mean decrease in the right ventricular–to–left ventricular ratio from baseline to 48 hours postprocedure of 0.45, which is significantly greater than the predefined performance goal of 0.12 (P < .001), and a major adverse event rate of 4.1, which is significantly lower than the predefined performance goal of 25% (P < .001). The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours postprocedure and a mean procedure time of 37.2 minutes.

On April 4, the company announced FDA 510(k) clearance of the AlphaVac F18⁸⁵ system for treatment of PE in the United States.