SANTA ROSA -- Medtronic CardioVascular's Resolute drug-eluting stent is featured prominently at the 60th Annual Scientific Session and Expo of the American College of Cardiology this week in New Orleans. Widely used outside the United States. the Resolute will launch in the United States, pending FDA approval, in the first half of 2012.
The one-year results of the U.S. clinical study, which completes Medtronic's FDA submission for the device's pre-market approval, were presented by Dr. Martin Leon of the NewYork-Presbyterian Hospital/Columbia University Medical Center, in a late-breaking clinical trials session for interventional cardiology and published by the Journal of the American College of Cardiology.
The two-year results of the Resolute All Comers study, a large randomized controlled trial comparing the Resolute to the Xience from Abbott Laboratories -- and, by extension, the Promus from Boston Scientific -- were presented yesterday as a featured clinical trial for interventional cardiology by Dr. Patrick Serruys of Erasmus University's Thoraxcenter in Rotterdam, the Netherlands and published by The Lancet.