Medtronic, Inc.: Medtronic to Appeal Federal District Court Ruling
MINNEAPOLIS- April 11, 2014 - The Federal District Court of Delaware today
granted in part Edwards Lifesciences' motion for a preliminary injunction that
prevents Medtronic, Inc. (NYSE: MDT) from selling or offering to sell its
CoreValve® System in the United States. Today's ruling has no impact on the
sale or marketing of CoreValve outside of the United States or the use of
CoreValve in the current U.S. clinical trials.
At Medtronic's request, the Federal District Court agreed to postpone the
implementation of the order for seven business days to allow Medtronic to seek
prompt relief from the Federal Circuit Court of Appeals. Medtronic is
appealing the Court's injunction, and intends to ask the Federal Circuit Court
of Appeals to prevent it from going into effect until it determines if the
injunction was properly issued.
In addition the Court ordered Medtronic and Edwards Lifesciences to enter into
discussions immediately to agree on a mechanism that will enable physicians at
facilities currently trained on CoreValve to make a clinical judgment as to
which device to implant (CoreValve or the Edwards device) free from the
limitations of the injunction. The Courtstated that CoreValve is a 'safer
device, and that patients in whom it is implanted have better outcomes with a
lower risk of death.' The Court also found that the public interest favors
enforcement of patent rights.
The CoreValve System received approval from the U.S. Food and Drug
Administration (FDA) in January for patients at extreme risk for surgical
valve replacement. Prior to that date, CoreValve therapy was available to
extreme risk patients who were eligible to participate in the U.S. clinical
trial. The CoreValve System is not yet approved in the U.S. for other patient
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers around the world.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology - alleviating pain, restoring health, and
extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities
and Exchange Commission. Actual results may differ materially from anticipated
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf
of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for
the content, accuracy and originality of the information contained therein.
Source: Medtronic, Inc. via Globenewswire
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