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November 18, 2014
Argon's Cleaner XT and Cleaner 15 Rotational Thrombectomy Systems Cleared for Mechanical Declotting and Infusion in the Peripheral Vasculature
November 19, 2014—Argon Medical Devices, Inc. announced that the company has received clearance from the US Food and Drug Administration to begin marketing the Cleaner XT and Cleaner 15 rotational thrombectomy systems for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature.
According to Argon, the new clearance enables the Cleaner to be available to physicians in the United States for cleaning wall-adherent thrombus to the peripheral vasculature when an inferior vena cava (IVC) filter is present. This indication augments Cleaner's existing clearance for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. Rex Medical, LP, designed Argon Medical Devices’ Cleaner family of rotational thrombectomy systems.
The company advised that the Cleaner rotational thrombectomy system is immediately available for use in the peripheral vasculature. Argon Medical Devices is formally launching the new indication at the ISET 2015: the 27th Annual International Symposium of Endovascular Therapy to be held January 31 to February 4, 2015, in Hollywood, Florida.
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