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Edwards Comments On German Court Decision

IRVINE, Calif., Oct. 23, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), 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. 

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.  Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.

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 expected timing and future impacts of the court's decision.  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, unanticipated outcomes from future appeals and legal proceedings and unanticipated changes in timing. 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, 2017. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards CENTERA, CENTERA, Edwards SAPIEN, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

 

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