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Edwards Wins Latest Round In TAVI Patent Dispute With Medtronic

This article was originally published in The Gray Sheet

Executive Summary

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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CoreValve May Go From “Superior” To Stalled Following Court Ruling

[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.

Edwards Plans To Keep ‘First-Mover’ Advantage In TAVI Against Emerging Competition

Edwards is counting on the Sapien XT valve, which will likely earn FDA approval soon, to compete with Medtronic’s recently approved CoreValve in the U.S, while in Europe the company is working quickly to upgrade customers to Sapien 3.

TAVR Market Heats Up As Medtronic’s CoreValve Wins Early FDA Approval

Medtronic Inc.’s CoreValve transcatheter aortic valve replacement (TAVR) device won FDA approval in January, months earlier than anticipated, setting the stage for a competitive battle in the US between Medtronic and market leader Edwards Lifesciences Corp. According to Jeffrey Popma, MD, the early approval can be attributed not only to the excellent design and execution of the CoreValve pivotal trial, but also to the new, more collaborative environment that is emerging at the US Food and Drug Administration.

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