The Federal District Court of Delaware today granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic, Inc. from selling or offering to sell its CoreValve System in the United States. Today's 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 U.S. Food and Drug Administration (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. The CoreValve System is not yet approved in the U.S. for other patient groups.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
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