Medtronic announced on Thursday that a German court has ordered the discontinuation of a prior court ruling that prohibited the Fridley-based company from marketing or selling its CoreValve transcatheter aortic valve replacement system in Germany.
Medtronic had been prohibited from selling CoreValve in Germany since August 26, after a lower German court ruled that Medtronic infringed on a patent by Edwards Lifesciences. Edwards also makes a transcatheter aortic valve.
But, on Thursday, a higher German court ruled that, because of a preliminary opinion by the European Patent Office that Edwards' patent claims are not valid, it could not assume that the Edwards patent is valid. Essentially, the higher court decided to discontinue enforcing the earlier patent infringement ruling.
"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."
Medtronic said it will post a required bond as soon as possible and resume sales in Germany.
CoreValve is not yet commercially available in the United States. Medtronic officials expect CoreValve to win U.S. regulatory approval sometime in 2014. Edwards' Sapien transcatheter aortic valve is currently the only such valve approved for use in the U.S., 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 hit the European market with its Portico valve.
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 couple of days, instead of weeks after the procedure.
