FDA Approves Longer Lengths of Medtronic's Resolute Integrity Stent

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 lesions.



"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

world.



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 periodic reports on file with the Securities and

Exchange Commission. Actual results may differ materially from anticipated

results.



                                    - end -





Contacts:

Joseph McGrath

Public Relations

+1-707-591-7367



Jeff Warren

Investor Relations

+1-763-505-2696





Coronary Artery Disease and Diabetes Backgrounder: 

 hugin.info/152439/R/1680616/549125.doc



Drug-Eluting Stent Procedural Animation: 

 youtu.be/uerMJMjo9_E



Resolute Integrity DES Long Lesion Image: 

 hugin.info/152439/R/1680616/549127.jpg



Resolute Integrity Fact Sheet: 

 hugin.info/152439/R/1680616/549129.doc







This announcement is distributed by Thomson Reuters on behalf of 

Thomson Reuters clients. The owner of this announcement warrants that: 

(i) the releases contained herein are protected by copyright and 

    other applicable laws; and 

(ii) they are solely responsible for the content, accuracy and 

     originality of the information contained therein. 

    

Source: Medtronic, Inc. via Thomson Reuters ONE

[HUG#1680616]