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News Breaks
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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July 28, 2014
12:46 EDTMDTMedtronic receives FDA approval for PRESTIGE cervical disc system
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11:07 EDTMDTLeerink medical devices analyst holds an analyst/industry conference call
Medical Devices Analyst Antalffy, along with MEDACorp Specialist Arie Pieter Kappetein, MD, PhD and Bernhard Meier, MD, assess EU cardiology trends on an Analyst/Industry conference call to be held on July 31 at 3 pm.
06:52 EDTMDTFormer official says Obama could limit inversion deals, NY Times reports
President Obama could limit tax inversion deals on his own authority, said Stephen Shay, former deputy assistant Treasury secretary for international tax affairs in the Obama administration, according to The New York Times. A 1969 law gives the president the ability to restrict inversion deals, said Shay, who also worked in the Reagan administration, the newspaper stated. Among the deals or possible transactions that involve inversion are Mylan's (MYL) acquisition of Abbott (ABT), Medtronic's (MDT) acquisition of Covidien (COV) and Valeant's (VRX) proposed takeover of Alletgan (AGN). Reference Link
July 25, 2014
06:30 EDTMDTObama calls on Congress to end inversion deals, NY Times reports
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July 24, 2014
08:19 EDTMDTLeerink medical devices analyst holds an analyst/industry conference call
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July 21, 2014
08:16 EDTMDTDeutsche Bank analysts hold an analyst/industry conference call
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July 18, 2014
12:51 EDTMDTKey GOP senator signals readiness for inversion deal, The Hill says
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