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News Breaks
April 13, 2014
15:10 EDTMDT, EWMedtronic says CoreValve ruling has no impact outside U.S.
The Federal District Court of Delaware granted in part Edwards Lifesciences' (EW) motion for a preliminary injunction that prevents Medtronic (MDT) from selling or offering to sell its CoreValve System in the United States. The ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials. At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued. In addition, the court ordered Medtronic and Edwards Lifesciences to enter into discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant, CoreValve or the Edwards device, free from the limitations of the injunction. The court stated that CoreValve is a 'safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.' The court also found that the public interest favors enforcement of patent rights. The CoreValve System received approval from the FDA in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial.
News For MDT;EW From The Last 14 Days
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July 22, 2014
07:57 EDTEWHouse Energy & Commerce Committee to hold a hearing
The Subcommittee on Health holds a hearing entitled, "21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication" with CEO Mussallem at Edwards Lifesciences on July 22 at 3 pm. Webcast Link
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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July 16, 2014
10:36 EDTMDTTreasury calls on Congress to halt inversion deals
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07:59 EDTMDTTreasury Secretary urges Congress to take action on tax inversions
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07:18 EDTMDTScoliosis Research Society to hold annual meeting
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July 14, 2014
07:12 EDTMDTCovidien downgraded to Neutral from Overweight at Piper Jaffray
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July 10, 2014
08:02 EDTMDTCryoLife appoints Pat Mackin as President and CEO effective September 2
Mackin is expected to be appointed to the company's board after his employment begins. Steven Anderson will continue to serve CryoLife (CRY) as its President and Chief Executive Officer until Mackin's employment begins and then continue as its Executive Chairman. Mackin joins CryoLife from Medtronic (MDT), where he most recently served as President of Cardiac Rhythm Disease Management.

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