Argon Medical’s Cleaner rotational thrombectomy systems receive FDA clearance

388

The US Food and Drug Administration has given Argon Medical clearance 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.

This clearance enables physicians to apply Cleaner’s capability for cleaning wall-adherent thrombus to the peripheral vasculature when an IVC filter is present. Venous thromboembolism is the third most prevalent cardiovascular illness following acute coronary syndrome and stroke, and it is estimated that there are approximately 1 million cases in the USA each year.

The Cleaner rotational thrombectomy system is immediately available for use in the peripheral vasculature, and Argon is formally launching the new indication at the 27th Annual International Symposium of Endovascular Therapy, to be held at the Diplomat Hotel in Hollywood, Florida, USA (31 January to 4 February, 2015).

“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,” states George Leondis, president of Argon Medical. “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.”

(Visited 118 times, 1 visits today)