New Clinical Trial First To Evaluate Effectiveness of CRT-P in Symptomatic Heart Failure Patients with Mild-to-Moderate Structural Heart Disease

Thu Jan 10, 2013 12:30pm EST

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Medtronic-Sponsored Study Aims to Support Worldwide Indication Expansion for CRT-P in a
Significantly Underserved Heart Failure Patient Population

MINNEAPOLIS - Jan. 10, 2013 - Medtronic, Inc. (NYSE: MDT) today announced the first patient
enrollment in MIRACLE EF, a global clinical trial that will evaluate the effectiveness of cardiac
resynchronization therapy-pacemakers (CRT-Ps) in delaying the progression of heart failure in
symptomatic patients with mildly reduced heart pumping function. This large study will be the
first to evaluate CRT-P in a widely underserved patient group - those who have a slightly reduced
left ventricular ejection fraction (LVEF) in the range of 36 to 50 percent, which means that their
hearts work somewhat more efficiently than heart failure patients who are currently indicated for
implanted device therapy because of their lower LVEF.  

The CRT-P devices used in MIRACLE EF are not approved by the FDA for the patient population being
studied. Edward Schloss, M.D., FACC, performed the first implant at The Christ Hospital's Lindner
Research Center in Cincinnati; primary investigator for the site is Greg Egnaczyk, M.D., Ph.D.,
FACC.

"Previous studies have proven the real-world therapeutic benefits of CRT in treating mildly to
severely symptomatic heart failure patients with moderately to severely reduced cardiac pumping
capacity and electrical dyssynchrony," said Professor Cecilia Linde, M.D., Ph.D., of Karolinska
University Hospital in Stockholm, and worldwide principal investigator in the trial. "Through this
large global study we hope to further our research on the overall effectiveness of CRT-P by
showing its benefit in treating patients with mild-to-moderate heart failure symptoms, but with
milder impairment of heart pumping capacity than previously studied."

Approximately 275 centers throughout the world, in regions including the United States, Canada,
Europe, Japan and developing markets, will enroll up to 2,300 patients who will receive a
Medtronic Consulta(R) CRT-P in this prospective, double-blind, randomized controlled trial.
Patients will be followed for at least two years or until close of the study. Medtronic
anticipates the trial will take four to five years to complete. The effectiveness of CRT-P in this
patient population will be assessed using a composite endpoint of time to first event, defined as
all-cause mortality or heart failure hospitalization. 

"We are hopeful that, when completed, MIRACLE EF will influence clinical practice guidelines
regarding the use of advanced cardiac resynchronization devices and potentially lead to another
expanded indication for Medtronic CRT devices," said David Steinhaus, M.D., vice president and
general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management
business at Medtronic. "We look forward to the positive implications these findings could have on
heart failure patients whose disease is less pronounced, yet who still experience symptoms and
need advanced therapeutic solutions."

In collaboration with leading clinicians, researchers and scientists, 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 worldwide.

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:
Tracy McNulty
Public Relations
+1-763-526-2492

Jeff Warren
Investor Relations
+1-763-505-2696


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Source: Medtronic, Inc. via Thomson Reuters ONE


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