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April 22, 2014

Federal court postpones injunction on Medtronic’s CoreValve system in US

The Federal Circuit Court of Appeals has granted a request from Medtronic to suspend the preliminary injunction that was ordered on 11 April to limit the sale of its CoreValve system in the US.

The Federal Circuit Court of Appeals has granted a request from Medtronic to suspend the preliminary injunction that was ordered on 11 April to limit the sale of its CoreValve system in the US.

According to the company, the injunction was previously scheduled to take effect on 23 April, and will now only occur if the appellate court rules that it was properly granted.

Last week, the Court of Appeals agreed to an expedited appeal of the injunction and the last appeal brief is due on 19 June.

Medtronic said it does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunction, particularly with respect to the impact it will have on the public interest.

"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."

Medtronic senior vice-president Dr John Liddicoat said: "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."

The CoreValve system received US Food and Drug Administration (FDA) approval in January for patients at extreme risk for surgical valve replacement.

Before then, CoreValve therapy was available to extreme risk patients who were eligible to participate in the US clinical trial. The CoreValve system is not yet approved in the US for other patient groups.

Medtronic said that this ruling has no impact on the sale or marketing of CoreValve outside of the US or the use of CoreValve in the current US clinical trials.

In March, data presented at the American College of Cardiology (ACC) annual meeting and simultaneously published in The New England Journal of Medicine showed superior results compared with surgical aortic valve replacement (SAVR) at one year in patients at increased risk for surgery.

It is claimed to be the first prospective and randomised study to show any transcatheter aortic valve to be superior to surgery. Medtronic anticipates FDA approval of the CoreValve system for high risk patients sometime this summer.

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