News | September 16, 2013

Transcatheter Heart Valve Injunction Initiated in Germany

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.

For more information: www.edwards.com

Related Content

Boston Scientific Projects 2019 Launch for Lotus Edge Aortic Valve System
News | Heart Valve Technology | February 23, 2018
February 23, 2018 — Boston Scientific announced In November 2017 a delay to timelines for commercialization of the Lo
Gate Bioprosthesis Used in Canada's First Transcatheter Valve Replacement for Tricuspid Regurgitation
News | Heart Valve Technology | February 22, 2018
NaviGate Cardiac Structures Inc. (NCSI)announced that on Feb. 2, 2018, its catheter-guided Gate valved-stent...
Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve has been approved with CE mark for use in Europe.
Feature | Heart Valve Technology | February 15, 2018
February 15, 2018 — Edwards Lifesciences Corp.
Boston Scientific Enters Investment and Acquisition Option Agreement With Millipede
News | Heart Valve Technology | January 24, 2018
Boston Scientific Corp. announced it has closed an investment and entered into an acquisition option agreement with...
Edwards LifeSciences Recalls Sapien 3 Certitude Delivery System
News | Heart Valve Technology | January 11, 2018
The U.S. Food and Drug Administration (FDA) announced that Edwards LifeSciences is recalling its Certitude Delivery...
Videos | Heart Valve Technology | January 04, 2018
Adam Greenbaum, M.D., co-director, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, explains how hi
Edwards Acquires Harpoon Medical
News | Heart Valve Technology | December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Videos | Heart Valve Technology | November 15, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, is the principal investigato
New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients
News | Heart Valve Technology | November 08, 2017
Medtronic plc recently presented new clinical research to support the positive clinical performance of the Evolut...
Overlay Init