Argon Medical Devices has obtained approval from the US Food and Drug Administration (FDA) for its Cleaner XT and Cleaner 15 Rotational Thrombectomy systems.
The systems have been developed for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics in the peripheral vasculature.
The FDA approval allows the physicians to apply Cleaner’s capability for cleaning wall-adherent thrombus to the peripheral vasculature when an IVC filter is present, said Argon.
Argon Medical Devices president George Leondis said: "Safely expanding the application of the CLEANER family of products to the peripheral vasculature means more effective therapy for patients suffering from peripheral thrombosis and occlusions.
"Combining an atraumatic approach with efficient thrombus removal is unique among thrombectomy devices, and we are excited to make this product available for a wider range of applications."
Argon noted the new indication augments Cleaner’s existing clearance for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The company will formally introduce the new indication at the 27th Annual International Symposium of Endovascular Therapy, which will be held from 31 January to 4 February 2015.
Rex Medical had designed the Cleaner family of Rotational Thrombectomy Systems, and is available from Argon.