Medtronic Completes
Enrollment in International Post-Market Study of Resolute Drug-Eluting
Stent
RESOLUTE International Examines Performance of Next-Generation DES in Standard
Clinical Practice
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May 14, 2009 -- Minneapolis --
Medtronic, Inc. (NYSE: MDT), today announced completion of enrollment
in RESOLUTE International, a post-market study of its Resolute Drug-Eluting
Stent (DES). One-year data from this international study, which enrolled
2,464 patients at 88 sites from 17 countries in Europe, Asia, Africa,
and Latin America, are expected in the second half of 2010.
“RESOLUTE International will expand our experience and understanding
of the Resolute DES in the setting of standard clinical practice,
which affords a degree of diversity in patient types and lesion characteristics
that are typically not well represented in tightly controlled clinical
trials,” said Prof. Dr. Franz-Josef Neumann of the Heart Center
of Bad Krozingen in Germany on behalf of his co-principal investigators,
Drs. Petr Widimský of the Faculty Hospital of Kralovske Vinohrady
in Prague and Jorge Belardi of the Cardiovascular Institute of Buenos
Aires. “Together with other data from the Resolute clinical
program, we expect the findings from RESOLUTE International to help
physicians make the best possible treatment decisions for the spectrum
of patients they see daily.”
RESOLUTE International is a prospective, multicenter observational
study with a composite primary endpoint of cardiac death and myocardial
infarction (not clearly attributable to a nontarget vessel) at one
year post-implant. It is part of the Resolute clinical program, which
will enroll a total of more than 6,000 patients at hundreds of clinical
research sites in more than 25 countries.
The Resolute DES draws on the strengths of
Medtronic’s Endeavor
DES. The products share the same cobalt alloy stent platform and
the potent antiproliferative drug zotarolimus. Both stents also feature
highly biocompatible polymers. The Resolute DES uses the BioLinx™ polymer,
Medtronic’s proprietary polymer designed specifically for use
on a DES. The BioLinx polymer is designed to extend the duration
of drug exposure in the vessel – an elution profile of potential
relevance to patients that physicians consider to be at high risk
of needing a repeat procedure – without trading off polymer
biocompatibility.
The Resolute DES received the CE (Conformité Européene)
mark in October 2007 and is commercially available in more than 100
countries worldwide. Approximately 100,000 patients have been treated
with the Resolute DES since its international launch. Use of the
Resolute DES in the United States is limited to investigational clinical
trials. The Resolute DES is part of Medtronic’s broad coronary
stents portfolio, which also includes the Endeavor Sprint DES and
the Driver and Micro-Driver Bare-Metal Stent.
About Medtronic
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
Annual Report on Form 10-K for the year ended April 25, 2008. Actual
results may differ
materially from anticipated results.
Source: Medtronic,
Inc.
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