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March 29, 2014
18:09 EDTMDTMedtronic's CoreValve shows superior results to surgical valve replacement
Medtronic announced that the CoreValve System showed results superior to surgical aortic valve replacement, SAVR, at one year in the High Risk Study of its CoreValve U.S. Pivotal Trial, which evaluated patients with severe aortic stenosis who are considered high risk for surgery. The data were presented at a late-breaking clinical trial session at the 63rd Annual Scientific Session of the American College of Cardiology, ACC, and simultaneously published in The New England Journal of Medicine. The CoreValve System was approved by the U.S. Food and Drug Administration, FDA, in January 2014 for patients considered extreme risk for surgery; the device is not currently approved in the U.S. for use with patients at high risk. The head-to-head study met its primary endpoint with a low one year, all-cause mortality rate of only 14.2% in patients receiving the CoreValve System, compared to 19.1% in patients receiving SAVR at one year. The CoreValve High Risk Study is the first prospective, randomized study to show any transcatheter aortic valve to be superior to surgery. "The extremely low mortality rates in both arms of the trial confirm that our heart teams were outstanding, particularly considering they had no prior experience with transcatheter aortic valve therapy, said David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at the Mount Sinai Hospital, New York City, national co-principal investigator of the CoreValve U. S. Pivotal Trial and presenter of the data at ACC. "Our key finding that TAVR with CoreValve was associated with a significantly higher rate of survival at one year in patients at increased risk has significant and broad implications."
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December 11, 2014
09:05 EDTMDTMedtronic receives FDA approval for Attain Performa LV quadripolar leads
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