Court Orders Medical Device Maker to Cease Marketing of Heart Valve in U.S.

Medtronic Inc., a U.S. medical device maker, was blocked from marketing CoreValve heart valve on April 14, after an injunction was issued by a federal court, according to the Wall Street Journal. The order was made on request by Edwards LifeSciences, a rival company of Medtronics.

The ruling followed a 2010 jury decision which found that CoreValve had infringed on Edwards’ U.S. patent on Sapien transcatheter valve product. Medtronic will have a seven day grace period, in which the court has agreed to delay implementation, to allow time for an appeal.

According to Medscape, reports from a CoreValve trial to test if it could include high-risk surgery patients found that results suggested CoreValve was statistically superior to high-risk surgery. The findings were challenged by experts following the presentation at the American College of Cardiology 2014 Scientific Sessions. The FDA has indicated that it will not be reviewing the evidence before making a decision on CoreValve’s expanded use.

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