Transcatheter Heart Valve Injunction Initiated in Germany


September 16, 2013
Edwards Lifesciences Medtronic Injunction Sapien XT Heart Valves Germany

September 16, 2013 — The injunction against sales of Medtronic's transcatheter heart valves in Germany — issued in a July 12, 2013, court ruling — has gone into effect, according to Edwards Lifesciences Corp. The District Court of Mannheim ruled that Medtronic is infringing Edwards' Spenser patent for transcatheter heart valve technology and issued an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany, and ordered a recall of these products. Edwards has now provided the bond required to initiate the injunction.

Putting the needs of patients first, Edwards has been preparing to provide a means for all patients in Germany to have ready access to life-saving transcatheter therapy. While Edwards believes it is important to protect its intellectual property to ensure continued innovation, the company is providing for exceptions to the injunction to ensure German physicians continue to have access to therapy in instances where the Edwards Sapien XT valve is not indicated, subject to Medtronic's cooperation. Edwards will not seek compensation for the valves used in these compassionate cases in Germany, which are estimated to be about 40 per month.

To enable the treatment of patients, Edwards has already reached out to all of the German centers that do not currently have experience with the Sapien XT valve to offer training and proctoring. More than 80 percent of the transcatheter valve centers in Germany currently utilize the Edwards Sapien XT valve.

The patent that was the subject of this court ruling, the Spenser patent EP 2 055 266 B1, is in effect until 2022. Medtronic is appealing this ruling, as well as contesting the validity of the Spenser patent at the European Patent Office.

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