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April 12, 2021
AngioDynamics Seeks FDA Clearance of AlphaVac Mechanical Thrombectomy System
April 12, 2021—AngioDynamics, Inc. announced that it has submitted a 510(k) application to the FDA for regulatory clearance of the AlphaVac system. AlphaVac is an off-circuit, multipurpose mechanical aspiration thrombectomy device for the treatment of undesirable intravascular material—including thrombus, embolus, and vegetation—in the venous system and peripheral vasculature.
According to the company, the AlphaVac system combines two AngioDynamics technologies: a new mechanical aspiration handle and a self-expanding funnel tip. It is designed to provide precise control in the removal of clot burden while minimizing patient blood loss.
Release of the AlphaVac system is anticipated in the second half of calendar year 2021, subject to FDA clearance, advised AngioDynamics.
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