Possis GuardDOG approved
This article was originally published in The Gray Sheet
Executive Summary
Occlusion guidewire system gains 510(k) clearance for peripheral use to "facilitate the infusion of therapeutic or diagnostic fluids, with or without vessel occlusion," the firm says. The 0.014 inch guide wire features a CO2 gas inflation mechanism. A pending IDE submission covers the product's use as a distal protection device when used with Possis Medical's AngioJet thrombectomy system in saphenous vein bypass graft patients as part of the upcoming FETCH trial. The AngioJet Xpeedior 120 catheter and Power Pulse Spray ancillary kit also gain 510(k) clearance for peripheral fluid infusion. A full commercial release of both products is expected by autumn...