Catch-up: Medtronic Wins CoreValve Stay and Covidien’s Pipeline Recall Gets FDA Class

Here in the UK, Easter Monday is a public holiday, so we’ve got a bit of catching up to do. While we’ve been digging our gardens and planting things the world of medtech has moved on with a few updates on last week’s stories.

First up comes the news that three appeal court judges have, albeit not unanimously, agreed to stay the earlier reported decision to place an injunction on sales of Medtronic’s CoreValve in the U.S.A. The original piece, as we reported it last week, is here. Two of the three appeal judges clearly decided that an injunction was not in the interest of patients, while the third was swayed by the original instruction and Edwards’ agreement to allow continued sales of CoreValve to existing facilities, where patient interest was a consideration. To say there’s bad blood flowing is sounding like an understatement however. Not only was the judge who made the original ruling,Gregory Sleet of the U.S. District Court for Delaware, unimpressed by Medtronic’s decision to appeal his decision, but Edwards Lifesciences too has decried the scare tactics used in arguing for a stay. Medtronic meanwhile says it is trying to find a workable solution that a near-term solution that addresses patient interest completely, but not one that “selectively and arbitrarily controls who has access to a device they need and who does not, regardless of where they live in the United States.”

The intractability of the situation is only heightened by the retort from Edwards CEO Mike Mussallem who’s clearly of the view that his company is being more than reasonable in the face of a clear infringement of its intellectual property. In a letter to clinicians he said; “In spite of the violations of our intellectual property, we are not seeking a total ban on CoreValve sales, because we understand the implications that could have for patients and physicians,” Mussallem wrote. “In fact, we put forward multiple offers, in court and directly to Medtronic, that would allow patients to continue to be treated with CoreValve. But, unfortunately, they have refused these offers. We encourage Medtronic to accept our standing offer to enable use of CoreValve at U.S. hospitals where it is commercially available today.”

In other news, following  Covidien’s voluntary recall of its Pipeline and Alligator neurovascular devices, for reason of potential PTFE coating delamination, the FDA has now issued its own recall and deemed it Class I. Class I is the FDA’s most serious category of recall, reserved for “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”


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