Medtronic, Inc. has announced that the European Patent Office has invalidated, in its entirety, the Edwards Lifesciences EP2055266 Spenser patent which was the basis for the Aug. 26, 2013 injunction prohibiting sales of the CoreValve System in Germany.
In its ruling, the EPO in The Hague said the entire patent is invalid and therefore revoked.
"Medtronic is very pleased with this ruling as it will ensure that patients across Europe who need aortic valve replacement will have access to this life-saving therapy," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business.
In October, the EPO issued a preliminary opinion that questioned the validity of this patent, and this led the Higher Regional Court Karlsruhe to order the discontinuation of the prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve System in Germany. Today's ruling is subject to further appeal.
The CoreValve System was designed specifically to overcome the challenges of a broad range of TAVR patients. The device has a small 18Fr profile for all four valve sizes, which minimizes trauma at implant, and allows physicians to treat patients with small or calcified vasculature. Its Nitinol frame is designed to prevent unwanted leakage and optimize blood flow. In addition, the CoreValve System is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.
The CoreValve System received CE Mark in 2007, and received U.S. Food and Drug Administration (FDA) approval for patients at extreme risk for surgery in January 2014.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.