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Federal District Court partially grants injunction preventing CoreValve sale in US
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The Federal District Court of Delaware has partially granted a motion for a preliminary injunction filed by Edwards Lifesciences to prevent Medtronic Inc. from selling its CoreValve transcatheter valve in the United States.
Implementation of the order, filed on April 11, was postponed for 7 business days to allow Medtronic to appeal the ruling, according to a company press release. The company will request that the Federal Circuit Court of Appeals prevent the injunction from going into effect until it is determined whether the injunction had been properly issued.
The District Court stated that the self-expanding transcatheter CoreValve System “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 ordered Medtronic and Edwards Lifesciences to establish an arrangement allowing physicians at facilities trained to use CoreValve to determine which of the companies’ devices to implant in a patient without being limited by the injunction.
CoreValve was approved by the FDA in January for use in patients with severe aortic stenosis at extreme high risk for surgical valve replacement. The ruling does not affect ongoing US clinical trials of CoreValve, or the sale or marketing of the device outside of the United States.
In 2012, the Federal Circuit Court of Appeals upheld an April 2010 federal jury decision that Medtronic had willfully infringed upon Edwards Lifesciences’ US Andersen transcatheter heart valve patent, and ordered the trial court to reconsider Edwards’ request for a permanent injunction prohibiting the manufacture and sale of CoreValve in the United States.