AngioDynamics Begins RECOVER-AV Trial in Europe for AlphaVac F18⁸⁵ System

September 19, 2024—AngioDynamics, Inc. announced the launch of the RECOVER AV trial of the company’s AlphaVac F18⁸⁵ multipurpose mechanical aspiration (MMA) system for the treatment of acute intermediate-risk pulmonary embolism (PE). The trial is designed to support the device’s adoption in the European market, where it is approved for the nonsurgical removal of thrombi or emboli from pulmonary arteries, including for treating PE.

According to the company, the prospective, multicenter, multinational, single-arm RECOVER-AV trial will evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy with AlphaVac F18⁸⁵. The trial is enrolling patients with confirmed acute, intermediate-risk PE at up to 20 hospital sites in Europe.

The primary efficacy endpoint is the reduction of the right ventricular/left ventricular ratio from baseline to 48 hours postprocedure. The primary safety endpoint is the incidence of major adverse events, including device-related death or major bleeding within 7 days. Patients will be followed for 12-months, with functional outcomes assessed at 30 days, 6 months, and 12 months.

AngioDynamics stated that the RECOVER AV study follows the APEX-AV study of acute pulmonary extraction with AlphaVac F18⁸⁵ system. APEX-AV is a single-arm study conducted under an FDA investigational device exemption. The study enrolled 122 patients with confirmed acute, intermediate-risk PE at 25 hospital-based sites in the United States.

The company stated that APEX-AV, which completed enrollment in December 2023, demonstrated that the AlphaVac F18⁸⁵ system is safe in patients with acute, intermediate-risk PE and provides significant improvement in right ventricular function and reduction in clot burden. The study findings were presented at SCAI 2024, the Society for Cardiovascular Angiography & Interventions scientific sessions held May 2-4 in Long Beach, California.

On May 24, AngioDynamics announced CE Mark approval for the AlphaVac F18⁸⁵ MMA system, which includes an ergonomic handle, an 18F cannula with an 85º angle, an obturator, and a waste bag assembly.