2013-02-25 15:08:32 -
New Sizes of Implantable Medical Device Target Long Coronary Lesions
Common Among Diabetes Patients
MINNEAPOLIS -- Feb. 25, 2013 -- Expanding the applicability of its marquee
product for the interventional treatment of coronary artery disease in the
United States, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food
and Drug Administration (FDA) has approved the 34mm and 38mm lengths of the
Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm
with an indication for patients with diabetes.
Now available to cardiac catheterization laboratories nationwide, these new
sizes of the Resolute Integrity stent enable the treatment of long coronary
lesions, which are generally
considered to span more than 27mm.
Like the core sizes approved by the FDA in February 2012, the 34mm and 38mm
lengths of the Resolute Integrity stent are uniquely indicated for treating the
coronary artery disease of patients with diabetes, who commonly present with
"Long coronary lesions and diabetes represent two distinct but often
interrelated clinical challenges," said Ronald Caputo, M.D., director of cardiac
services and cardiology research at St. Joseph's Hospital in Syracuse, N.Y.
"The new sizes of the Resolute Integrity drug-eluting stent address both
challenges in a single device. They have the potential to reduce procedure time
and cost for clinicians and hospitals, as well as vessel trauma and contrast
exposure for patients."
FDA approval of the 34mm and 38mm lengths of the Resolute Integrity stent is
based on data from the global RESOLUTE clinical program -- specifically, a pre-
specified analysis of one-year outcomes in patients with long coronary lesions
who participated in the RESOLUTE US and RESOLUTE Asia studies.
The analysis included data on 222 patients who received a 38mm Resolute stent
for the treatment of coronary lesions of no greater than 35mm in length. The
primary endpoint for the analysis was target lesion failure (TLF) -- a composite
of cardiac death, target vessel myocardial infarction and clinically-driven
target lesion revascularization (TLR) -- at one year of follow-up.
The long-lesion analysis met its primary endpoint, with a one-year TLF rate of
4.5 percent. Among the 38 percent of patients with diabetes, the one-year TLF
rate was similarly low at 6.0 percent. The one-year rates of clinically driven
TLR for all patients and the subset of diabetes patients were 1.4 percent and
2.4 percent, respectively.
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
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
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Coronary Artery Disease and Diabetes Backgrounder:
Drug-Eluting Stent Procedural Animation:
Resolute Integrity DES Long Lesion Image:
Resolute Integrity Fact Sheet:
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Source: Medtronic, Inc. via Thomson Reuters ONE