“Medtronic is very pleased with this decision as it will ensure that patients in Germany 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. “As a result of the ruling, Medtronic will resume distribution of the Corevalve System in Germany.”
The Higher Regional Court Karlsruhe explained that, due to the European Patent Office preliminary opinion that the Edwards’ EP2055266 Spenser patent claims are not valid, it could not assume “with sufficient likelihood” that the Spenser patent is valid.
Medtronic will post the $6.7 million bond required by the order “as soon as possible” and then resume sales in Germany.
Irvine, Calif.-based Edwards Lifesciences released a statement on its website detailing the bare bones of the reversed court ruling. No executives commented.
CoreValve is not yet commercially available in the United States. Medtronic officials expect CoreValve to win U.S. regulatory approval next year 2014. Edwards’ Sapien transcatheter aortic valve is currently the only such valve approved for use in the United States, and only for patients considered extreme risk for open heart surgery.
Last month, Boston Scientific announced European approval of its Lotus transcatheter valve. Last year, St. Jude released its Portico valve to the European market.
Transcatheter aortic valve replacement allows doctors to insert a new valve into the heart by snaking a catheter up into the patient through an artery in the leg or through an incision in the upper body. It is a much less invasive procedure than open-heart surgery and patients can be home from the hospital within a few days instead of weeks after the procedure.