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Federal Appeals Court postpones injunction blocking CoreValve sale in US
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The Federal Circuit Court of Appeals has postponed the implementation of an injunction filed by Edwards Lifesciences to prevent Medtronic Inc. from marketing its CoreValve transcatheter valve in the United States.
Medtronic argued that Edwards Lifesciences had not met the standards necessary to file such an injunction, and had previously been granted a postponement of 7 business days to appeal the ruling after the initial order on April 11. As a result of this latest postponement, the injunction will only go into effect if the appellate court determines it had been properly issued, according to a press release.
“We believe this ruling is good news for patients who need the CoreValve device, and our primary objective has been to work closely with physicians to ensure that their patients are able to get the therapy they need,” John Liddicoat, MD, senior vice president of Medtronic and president of the Medtronic Structural Heart Business, said in the release.
The Court of Appeals also granted an expedited appeal of the initial ruling to Medtronic, with the final appeal brief to be submitted by June 19.
The self-expanding CoreValve device was approved by the FDA in January for use in patients with severe aortic stenosis at extreme high risk for surgical valve replacement. The approval was granted without the assessment of an external panel of experts, due to strongly favorable results from study of the CoreValve System among high-risk patients.
The injunction would not affect ongoing US clinical trials of CoreValve, or the sale or marketing of the device outside of the United States.