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October 26, 2011
FDA Expands Indication for NexGen's Xcoil Retractor for DVT Treatment
October 27, 2011—NexGen Medical Systems, Inc. (Melbourne, FL) announced that the US Food and Drug Administration has granted 510(k) clearance of an expanded indication for the company's Xcoil Retractor thrombectomy device to include the removal of blood clots in patients with deep vein thrombosis.
According to NexGen, the indications for use of the device are “removal of embolic/thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from dialysis grafts and arteriovenous fistulas.”
The Xcoil deploys multiple coils behind, through, and in front of blood clots that are then cinched together to firmly ensnare hard clots, as well as more bulky soft clots, removing them quickly and easily without thrombolytic drugs and without damaging venous valves, the company stated.
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