Transcatheter Heart Valve Injunction Initiated in Germany IRVINE, CA -- (Marketwired) -- 08/26/13 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the injunction against sales of Medtronic's transcatheter heart valves in Germany -- issued in a July 12, 2013, court ruling -- has today gone into effect. The District Court of Mannheim ruled last month 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 don't 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. About Edwards Lifesciences Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements regarding patient access and the status of site training. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, the level of cooperation by Medtronic and unforeseen challenges with implementing the injunction. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2012. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN XT and SAPIEN XT are trademarks of Edwards Lifesciences Corporation. Media Contact: Sarah Huoh 949-250-5070 Investor Contact: David K. Erickson 949-250-6826
Transcatheter Heart Valve Injunction Initiated in Germany
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