This article was originally published in The Gray Sheet
Premarket approval application is filed with FDA covering the AngioJet Rheolytic thrombectomy system to remove blood clots from coronary blood vessels. The Minneapolis firm has requested expedited review for the submission, which includes results of a 349-patient randomized trial comparing AngioJet to intracoronary infusion of urokinase in patients with demonstrated clot in native coronary arteries and saphenous vein bypass grafts. The trial showed that AngioJet patients "had significantly better outcomes...for procedure success and device success," Possis claims. The product currently is approved for treatment of dialysis access graft thrombosis
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