We Are Currently Enrolling in This Study.
The Recover-AV Trial is a Prospective, Multicenter, Multinational Study Evaluating the Effectiveness and Safety of the Alphavac Multipurpose Mechanical Aspiration (MMA) F1885 System for the Treatment of Acute Intermediate Risk Pulmonary Embolism (PE).
The RECOVER-AV Trial is a prospective, multicenter, multinational study evaluating the effectiveness and safety of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism (PE). This single-arm trial aims to assess the long-term functional outcomes of percutaneous mechanical aspiration thrombectomy in patients with confirmed acute, intermediate-risk PE.
The primary goal of the RECOVER-AV trial is to support the adoption of the AlphaVac F1885 System in the Global market by demonstrating its safety and efficacy in treating acute, intermediate-risk PE. The trial is being conducted across up to 20 hospital sites globally, with a targeted enrollment of patients who meet the eligibility criteria.
Primary Efficacy Endpoint: Reduction of the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure.
Primary Safety Endpoint: Incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented.
The AlphaVac F1885 System is an emergent first-line device that is currently CE marked for the non-surgical removal of thromboemboli from the pulmonary arteries and for the treatment of PE. The AlphaVac F1885 System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
Please fill out the fields below if you are looking to be contacted to learn more about the RECOVER-AV study.
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US and Canada Indications for Use:
The Cannula is indicated for:
The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.
EU Indications for Use:
The Cannula is indicated for:
The Cannula is intended for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.
US and Canada Contraindications:
The following contraindications are applicable:
EU Contraindications:
The following contraindications are applicable:
Warnings:
Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.
Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
AlphaVac is a trademark and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.