AngioDynamics Announces First Patient Enrolled in RECOVER-AV Trial for Acute Pulmonary Embolism Treatment

AngioDynamics has commenced the RECOVER-AV clinical trial to evaluate the AlphaVac F1885 System for treating acute pulmonary embolism. The trial spans multiple countries and aims to assess the system's safety and efficacy in intermediate-risk PE patients. Following previous successful trials, the study aims to provide a comprehensive assessment of patient recovery. The primary safety endpoint will gauge adverse events over a 12-month period, with patient follow-ups assessing functional and quality-of-life outcomes at 30 days and 12 months.

AngioDynamics, Inc. (NASDAQ: ANGO), a leading medical technology company, has announced the commencement of the RECOVER-AV clinical trial to evaluate the AlphaVac F1885 System for treating acute pulmonary embolism (PE). The trial is a prospective, multi-center, multi-national, single-arm study designed to assess the safety and efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in intermediate-risk PE patients across Europe, Canada, and Hong Kong.

The RECOVER-AV trial 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 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 comprehensive assessment of long-term recovery.

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 trial is led by co-Principal Investigators Erik Klok, MD, and Andrew Sharp, MD, who are both renowned experts in their fields. Professor Klok, from Leiden University Medical Center, and Professor Sharp, from Mater Misericordiae Hospital and University College Dublin, are pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients.

The AlphaVac F1885 System is an emergent first-line device currently CE marked for the non-surgical removal of thromboemboli from the pulmonary arteries and for the treatment of PE. The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.

AngioDynamics aims to broaden access to life-saving PE treatment across Europe and the wider global market. The company's innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs.

The RECOVER-AV trial builds on the results of the Company’s U.S.-based APEX-AV trial, which demonstrated the safety and effectiveness of the AlphaVac F1885 System in intermediate-risk PE patients, with significant improvements in right ventricular function and reduction in clot burden [2].

For more information about the RECOVER-AV clinical trial, visit https://www.angiodynamics.com/studies/recover-av/. For important risk information, visit www.angiodynamics.com/about-us/risk-information/.

References:
[1] https://www.biospace.com/press-releases/angiodynamics-announces-first-patient-enrolled-in-recover-av-clinical-trial-evaluating-alphavac-f1885-system-for-treatment-of-acute-pulmonary-embolism
[2] https://www.businesswire.com/news/home/20250623334762/en/AngioDynamics-Announces-First-Patient-Enrolled-in-RECOVER-AV-Clinical-Trial-Evaluating-AlphaVac-F1885-System-for-Treatment-of-Acute-Pulmonary-Embolism