Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that today the district court in Düsseldorf, Germany, granted Boston Scientific’s request for a preliminary injunction on future commercial sales and, therefore, patient treatments using the Edwards SAPIEN 3 Ultra valve in Germany. The injunction will only become effective if Boston Scientific enforces it and provides a bond of €10 million.
The SAPIEN 3 Ultra valve is not yet approved for commercial sale and is the subject of a clinical study for European approval, which will continue. The decision has no effect on sales of the company’s SAPIEN 3 or CENTERA valves. Edwards will promptly appeal and believes it will ultimately prevail.
This case pertains to the German part of Boston Scientific’s European patent No. EP 2 949 292. The German court will hold a full hearing on the merits of the dispute in mid-2019.