American College Of Cardiology 2002 Meeting In Brief
This article was originally published in The Gray Sheet
Executive Summary
Was the panel InSync?: "It was unfortunate that there was an impression left with people at the [March 5 circulatory system] panel meeting that somehow something less than all of the data was presented," Medtronic Cardiac Rhythm Management President Steve Mahle said during a March 16 investors call. "There were in fact 71 [additional] patients who met the six-month endpoint prior to the panel meeting. However, the agency "asked us not to submit [that data] because [there] wasn't time [for it] to be submitted to the panel" before the originally scheduled meeting in January. The panel voted 5-4 to recommend approval of the InSync ICD (1"The Gray Sheet" March 11, 2002, p. 3). Data from the 362-patient MIRACLE ICD trial, showing improvement in quality of life, exercise tolerance and functional class, were presented by James Young, MD, The Cleveland Clinic, at the ACC Scientific Sessions annual meeting in Atlanta on March 20...