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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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August 25, 2015
09:07 EDTMDTMedtronic to acquire Twelve for $458M
In support of the company's therapy innovation strategy, Medtronic announced that it has signed a definitive agreement to acquire Twelve, a medical device company focused on the development of a transcatheter mitral valve replacement, or TMVR device. Twelve is the twelfth company spun out from the premier medical device incubator The Foundry. Medtronic has agreed to pay up to $458M for Twelve including $408M at closing and $50M on achievement of CE Marking. The cash- and debt-free transaction remains subject to customary closing conditions, and is expected to close in October 2015.
August 24, 2015
08:29 EDTEWWilliam Blair to hold a field trip
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