Landmark Medtronic CoreValve® U.S. Clinical Trial Begins
Investigational Therapy Offers Treatment Alternative to Open Heart-Surgery for Patients with Severe Aortic Stenosis
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Medtronic's
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December 21, 2010 --
Minneapolis -- Medtronic, Inc. (NYSE: MDT) today announced the beginning
of its Medtronic CoreValve® U.S. Pivotal clinical trial in the
United States. The first CoreValve transcatheter aortic valve
implantation (TAVI) procedure was performed by David H. Adams,
M.D., and Samin K. Sharma, M.D., at The Mount Sinai Medical Center
in New York City. The Medtronic CoreValve® System, a revolutionary
treatment alternative to open-heart surgery for patients with
severe aortic stenosis, will be investigated in more than 1,200
patients at up to 40 U.S. clinical trial sites. |
A second CoreValve case took place this week
at El Camino Hospital in Mountain View, Calif.; St. Francis Hospital,
The Heart Center in Roslyn, N.Y, also has been activated in the trial
and is screening patients.
“Through this trial, we are investigating a minimally invasive, non-surgical alternative to open-heart surgery for valve replacement in patients with severe aortic stenosis,” said Dr. Adams, who is chair of the Department of Cardiothoracic Surgery at Mount Sinai and is a national co-principal investigator of the CoreValve U.S. clinical trial. “This
study will evaluate the safety and efficacy of the CoreValve system
for use in the United States, where many thousands of patients are
diagnosed with severe aortic stenosis every year.”
The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously (through the skin), usually through the femoral artery, without open-heart surgery or surgical removal of the native valve. The CoreValve device is delivered through a controlled deployment delivery system.
“We are very excited with this first step in bringing this important transformational therapy to patients in the United States with life-threatening aortic valve disease, particularly those patients who have limited surgical options,” said
Jeffrey Popma, M.D., national co-principal investigator of the Medtronic
CoreValve U.S. Pivotal Trial and director, Interventional Cardiology
at the Beth Israel Deaconess Medical Center in Boston.
About Symptomatic Severe Aortic Valve Stenosis
Aortic stenosis is a condition where the aortic valve narrows, thereby limiting blood flow from the aorta to the rest of the body. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.
Worldwide, approximately 300,000 people have
been diagnosed with severe aortic stenosis (100,000 in the U.S.), and
approximately one-third of these patients are deemed at too high a
risk for open-heart surgery,1 the only
therapy with significant clinical effect currently available in the
United States.
About the Medtronic CoreValve U.S. Pivotal Clinical Trial
The Medtronic CoreValve System with the AccuTrak™ stability layer will
be investigated in two independent studies, evaluating patients who
have been deemed at high risk for aortic valve surgery, and those who
have been deemed at extreme risk for aortic valve surgery (i.e. inoperable).
Clinical sites across the U.S. will be identified on www.clinicaltrials.gov.
For more information about the Medtronic CoreValve U.S. Clinical Trial,
see www.aorticstenosistrial.com.
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.
1 Iung B, Cachier A, Baron G, et al. Decision-making
in elderly patients with severe aortic stenosis: why are so many
denied surgery? Eur Heart J. 2003;26:2714-2720.
Source: Medtronic,
Inc.
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