MINNEAPOLIS – The Federal District Court of Delaware on Friday 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.
The ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of the product in current U.S. clinical trials, according to the release from Medtronic.
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 of the two devices to implant, 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,” according to the release. 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 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.