CoreValve May Go From “Superior” To Stalled Following Court Ruling
This article was originally published in The Gray Sheet
[Updated to incorporate comments from Edwards and Medtronic about ongoing negotiations, and more details on Medtronic’s emergency motion] A preliminary injunction ruling for Medtronic’s CoreValve device is an unexpected twist in a long-running transcatheter aortic valve patent suit between Medtronic and Edwards Lifesciences, and could give Edwards a significant edge in the market for several years to come.
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Data from Medtronic’s CoreValve High Risk Study provide the firm with significant momentum toward expanding the FDA label for its transcatheter aortic valve replacement device. Based on the results, FDA says no advisory panel will need to meet for the firm’s high-risk surgery submission. Observers say the jury is still out on CoreValve versus Sapien question.
A jury in Delaware awarded Edwards $393.6 million in damages plus royalties after determining Medtronic’s CoreValve infringes Edwards’ Cribier patent. While Medtronic might be paying royalties to Edwards for the next several years, Medtronic also got some very positive news last week: FDA approved CoreValve for patients too sick for surgery months earlier than expected.
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