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



2013-01-10 18:33:28 -


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(®) 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.


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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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