Patient Enrollment Begins in Study of AngioDynamics’ AlphaVac F1885 System

AngioDynamics Inc. has enrolled the first patient in a prospective, multi-center study evaluating the efficacy of its AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in treating acute, intermediate-risk pulmonary embolism (PE).

The RECOVER-AV study follows last April’s U.S. Food and Drug Administration (FDA) 510(k) clearance of the AlphaVac F1885 System and its May 2024 CE Mark approval. The trial will determine whether the AlphaVac F1885 System is safe and effective to use, and it will 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) countries.¹

“The first patient enrollment 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, at AngioDynamics. “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 single-arm 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 patient recover after mechanical thrombectomy with the AlphaVac MMA F1885 System.

The RECOVER-AV trial is led by co-principal investigators Erik Klok, M.D., professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center; and Andrew Sharp, M.D., 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,” Dr. Klok stated. “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, M.D., Ph.D., 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,” Dr. Araszkiewicz commented. “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 results of the company’s U.S.-based APEX-AV trial,² which demonstrated 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 PE frontline treatment and expand options for healthcare providers managing patients with life-threatening venous thromboembolism. The AlphaVac F1885 System is an emergent first-line device that is currently CE marked to non-surgically remove thromboemboli from the pulmonary arteries and treat PE. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.

AngioDynamics is a 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.

References
¹ Willich SN, Chuang LH, van Hout B, Gumbs P, Jimenez D, Kroep S, Bauersachs R, Monreal M, Agnelli G, Cohen A. Pulmonary embolism in Europe – Burden of illness in relationship to healthcare resource utilization and return to work. Thromb Res. 2018 Oct;170:181-191.
² Ranade M, Foster MT 3rd, Brady PS, Sokol SI, Butty S, Klein A, Maholic R, Safar A, Patel T, Zlotnick D, Gans D, Pollak J, Ferrera D, Stegman B, Basra S, Moriarty J, Keeling B. Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial. J Soc Cardiovasc Angiogr Interv. 2024 Dec 27;4(1):102463.