The Wall Street Journal reported Medtronic Inc. has been blocked from marketing its new CoreValve heart valve in the US, following an injunction issued by a Federal court. The court issued the order on a request made by rival Edwards Lifesciences. The paper noted the ruling by US District of Delaware by chief judge Gregory M. Sleet followed a 2010 jury decision that found the CoreValve infringed on the Edwards’ US patent on Sapien transcatheter valve product.
Reuters reported the court has agreed to delay implementing its order for seven day, giving Medtronic more time to file an appeal. Medtronic disclosed Monday it has filed a motion, urging a stay on the preliminary injunction blocking its sale of CoreValve device, the article noted.
Medscape reported that last month, results “from the pivotal trial required to expand the CoreValve indication to include high-risk surgery patients were” unveiled at the American College of Cardiology 2014 Scientific Sessions. “Those trial results suggested that the CoreValve was both statistically noninferior and superior to high-risk surgery, although the analyses underpinning the superiority finding were challenged by experts following the presentation,” the article noted. According to Medscape, the FDA has already indicated “it will not be requiring its advisory panel to review the evidence before the agency makes its decision on expanding the indications for use.”
Cardiovascular Business also covered the story.
From the American Association for Justice news release.