The multi-centre, multi-national study builds on existing U.S. PE Clearance and CE Mark to assess mechanical thrombectomy treatment and long-term functional outcomes in intermediate-risk PE patients across Europe
AngioDynamics, Inc., a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving patient quality of life, has announced the first patient has been enrolled in the RECOVER-AV clinical trial, a prospective, multi-centre, multi-national, single-arm study evaluating the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute, intermediate-risk pulmonary embolism (PE).
The study follows the United States Food and Drug Administration (FDA) 510(k) clearance of the AlphaVac F1885 System for the treatment of PE in the United States in April 2024 and its CE Mark approval in Europe in May 2024. 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 following treatment.
The prevalence of PE in Europe is significant, particularly among hospitalized and older populations. An estimated 435,000 PE events occur annually in the six largest European Union (EU) countries1.
“The first patient enrolment in the RECOVER-AV trial marks an important step forward as AngioDynamics continues to grow its global clinical presence and commitment to evidence-based care,” said Laura Piccinini, Senior Vice President/General Manager, Cardiovascular and International. “With AlphaVac already 510(k)-cleared in the U.S. and CE-marked in Europe for PE, we’re investing in high-quality data focused on functional recovery and quality of life that will equip clinicians, payers, and patients with even greater confidence in the system’s safe, effective performance and help broaden access to life-saving PE treatment across Europe and the wider global market.”
The trial is enrolling 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.
The RECOVER-AV trial is led by co-Principal Investigators Erik Klok, MD, Professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center, and Andrew Sharp, MD, Professor of Interventional Cardiology at Mater Misericordiae Hospital and University College Dublin.
“Pulmonary embolism continues to be a leading cause of morbidity and mortality across Europe, underscoring the need for treatment strategies that are both safe and effective,” said Professor Klok. “We’re pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients.”
Aleksander Araszkiewicz, MD, PhD, Assistant Professor at Poznan University of Medical Sciences in Poland, completed the first procedure as part of the trial.
“Performing the first case in the RECOVER-AV study marks an important step forward in expanding treatment options for patients with intermediate-risk pulmonary embolism,” said Prof. Araszkiewicz. “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.”
This study builds on the results of the Company’s U.S.-based APEX-AV trial2, which demonstrated that the AlphaVac F1885 System is safe and effective for use in intermediate-risk PE patients, with significant improvements in right ventricular function and reduction in clot burden.
The AlphaVac F1885 System received CE Mark approval in May 2024 for the non-surgical removal of thrombi or emboli from the pulmonary arteries. The System is designed to support frontline treatment of PE and expand options for healthcare providers managing patients with life-threatening venous thromboembolism.
