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News Breaks
April 13, 2014
15:10 EDTEW, MDTMedtronic 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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March 3, 2015
08:37 EDTMDTFlex Pharma announces investment from Medtronic
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March 2, 2015
12:59 EDTMDTAppeals court ruling a positive for NuVasive, says Wells Fargo
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12:54 EDTMDTNuVasive gets mixed appeals court ruling in patent fight with Medtronic
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08:55 EDTMDT, EWEdwards Lifesciences Medtronic likely to get positive catalyst, says Wells Fargo
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February 27, 2015
09:02 EDTMDTMedtronic announces Irish High Court approval of share premium reduction
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February 24, 2015
13:02 EDTMDTMedtronic confirms FDA approval of VenaSeal closure system
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February 23, 2015
08:40 EDTMDTMedtronic acquires Advanced Uro-Solutions, terms not disclosed
Medtronic announced that it has acquired Advanced Uro-Solutions, a privately-held developer of neurostimulation products for the treatment of bladder control issues based in Elizabethton, Tennessee. Terms of the acquisition agreement, which closed in December 2014, were not disclosed.
February 20, 2015
12:19 EDTMDTFDA approves closure system to permanently treat varicose veins
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February 19, 2015
16:15 EDTMDTMedtronic SANTE trial data show sustained safety, improvements in QOLIE-31
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