Edwards Wins Limit on U.S. Sales of Medtronic CoreValve

Edwards Lifesciences Corp. won a court order limiting U.S. sales of Medtronic Inc.’s CoreValve system, a device approved by the Food and Drug Administration in January that was found to infringe Edwards patents.

The preliminary order will go into effect in seven business days, the companies said in separate statements. U.S. District Judge Gregory M. Sleet in Wilmington, Delaware, granted Edwards’s request in part and will follow up with a written order, according to a note today on the court’s website.

Edwards and Medtronic are fighting for control of the developing market, valued to reach $3 billion a year, for heart valves that can be inserted without open-heart surgery. Medtronic’s CoreValve and Edwards’s Sapien XT are designed to help 300,000 people worldwide with aortic stenosis, a narrowing of the valve between the left ventricle and the aorta.

The judge ordered the companies to confer on continued use of the CoreValve at medical centers where physicians are trained on its use, according to the companies’ statements.

Medtronic, based in Minneapolis, said it will appeal the U.S. sales ban.

‘Safer Device’

“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,” the company said in a statement. “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.’”

Edwards, based in Irvine, California, in 2010 won a jury verdict that the Medtronic device infringed one of its patents. The U.S. Supreme Court in October refused to review an appeals court’s decision upholding the $73 million verdict.

In a separate case, Edwards was awarded $392.5 million in damages on claims the Medtronic device infringed another patent. Medtronic is appealing that verdict.

Edwards last month asked Sleet to permanently bar U.S. sales of the CoreValve.

The case is Edwards Lifesciences AG v. CoreValve Inc., 08-cv-00091, U.S. District Court, District of Delaware (Wilmington).

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