Medtronic/Edwards TAVI Duel Plays Out as German Injunction Shuts Door on CoreValve

In a news release on its website on August 26th, Edwards Lifesciences Corporation announced that the injunction against sales of Medtronic’s transcatheter heart valves in Germany had gone into effect. In a magnanimous gesture, Edwards is allowing for exceptions where its own Sapien valve is not indicated, but Medtronic’s CoreValve is.

Background

This, as we’ve covered in the past, is all about patent infringement as the two global leaders in transcatheter valve technology slug it out for domination of the evolving market. A German court had ruled last month that Medtronic is infringing Edwards’ so-called “Spenser” patent and accordingly issued an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany, also ordering a recall of these products. Edwards has now provided the bond required to initiate the injunction.

Edwards say s it has been preparing to provide a means for all patients in Germany to have ready access to life-saving transcatheter therapy, which is what has resulted in it 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.

While more than 80 percent of the transcatheter valve centers in Germany currently utilize the Edwards SAPIEN XT valve, Edwards has already reached out to all of the German centers that don’t currently have experience with its device to offer training and proctoring.

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.

Source: Edwards Lifesciences Corporation.