AngioDynamics Enrolls First Patient in RECOVER-AV Trial of Acute PE

June 23, 2025—AngioDynamics, Inc. announced first patient enrollment in the RECOVER-AV clinical trial. The prospective, multicenter, multinational, single-arm study is evaluating the company’s AlphaVac multipurpose mechanical aspiration (MMA) F18⁸⁵ system in the treatment of acute, intermediate-risk pulmonary embolism (PE).

According to AngioDynamics, the RECOVER-AV trial is designed to evaluate the safety and efficacy of the AlphaVac F18⁸⁵ system in support of its adoption in the global market, as well as to assess long-term functional outcomes for patients after treatment.

Aleksander Araszkiewicz, MD, who is Assistant Professor at Poznan University of Medical Sciences in Poznan, Poland, completed the first procedure as part of the trial, stated the company.

“Performing the first case in the RECOVER-AV study marks an important step forward in expanding treatment options for patients with intermediate-risk PE,” commented Prof. Araszkiewicz in the company’s press release. “The AlphaVac F18⁸⁵ system offers a promising mechanical thrombectomy solution, and I’m encouraged by its ease of use and the immediate clinical results we observed. I look forward to continuing to contribute to this critical research as we work to improve outcomes for PE patients.”

The RECOVER-AV trial is led by Coprincipal Investigators Professor Erik Klok, MD, and Andrew Sharp, MD.

“PE continues to be a leading cause of morbidity and mortality across Europe, underscoring the need for treatment strategies that are both safe and effective,” commented Prof. Klok in the company’s press release. “We’re pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients.”

AngioDynamics summarized the RECOVER-AV trial design as follows:

• It will enroll patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites in Europe, Canada, and Hong Kong.
• The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months.
• Patients will be followed for 12 months, with functional and quality-of-life outcomes assessed at 30 days and 12 months.

Additional investigations, including cardiac MRI and exercise testing, will provide a more comprehensive assessment of the long-term recovery of patients after mechanical thrombectomy with the AlphaVac MMA F18⁸⁵ system, advised AngioDynamics.

In September 2024, the company announced it would initiate the RECOVER-AV trial in Europe. In May 2024, the company announced European CE Mark approval of the AlphaVac F18⁸⁵ system for the nonsurgical removal of thrombi or emboli from the pulmonary arteries.

FDA 510(k) clearance of the AlphaVac F18⁸⁵ system for the treatment of PE in the United States was announced in April 2024.

Angiodynamics stated that the RECOVER-AV study builds on the results of the company’s United States-based APEX-AV trial, which demonstrated that the AlphaVac F18⁸⁵ system is safe and effective for use in intermediate-risk PE patients, with significant improvement in right ventricular function and reduction in clot burden. In May 2024, the company announced that the APEX-AV findings were presented at the Society for Cardiovascular Angiography & Interventions scientific sessions.