AngioDynamics, Inc. Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System
April 12, 2021 at 06:00 am EDT
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AngioDynamics, Inc. announced that on April 9, 2021, it submitted a 510(k) application to the United States Food and Drug Administration (FDA) for the AlphaVac System, an off-circuit, multi-purpose mechanical aspiration thrombectomy device for the treatment of undesirable intravascular material in the venous system and peripheral vasculature. The AlphaVac System combines two of AngioDynamics’ proprietary technologies: a new mechanical aspiration handle and the Company’s innovative self-expanding funnel tip and is designed to provide precise control in the removal of clot burden while minimizing patient blood loss. Undesirable intravascular material can include thrombus, embolus, and vegetation found in a patient’s venous system, including the peripheral vasculature. AngioDynamics anticipates the release of the AlphaVac System in the second half of calendar year 2021, subject to FDA clearance.
AngioDynamics, Inc. is a transformative medical technology company. The Company is focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. It designs, manufactures, and sells a range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. Its devices are generally used in minimally invasive, image-guided procedures. Its segments include Med Tech and Med Device. Its product categories include oncology, venous therapies, vascular interventions, and ports. Its oncology products include Model 1500X RF Generator, IsoLoc Endorectal Balloon, Habib 4X Laparoscopic Bipolar Resection Device, Habib 4X Bipolar Resection Device, and Alatus. Its venous therapies include VenaCure EVLT 1470 Pro Laser, VenaCure EVLT System, VenaCure EVLT Procedure Packs, and others.
ANGIODYNAMICS, INC. 
