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
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.
David K. Erickson
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