Multiple European Clinical Registries Show Important Benefits of Medtronic CoreValve® Transcatheter Aortic Valve System
Data Demonstrates That Revolutionary Treatment for Patients with Diseased Heart Valves Is Transitioning Successfully into Standard Clinical Practice throughout Europe
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Medtronic's CoreValve |
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May 25, 2010 -- Paris --
New European data from five national clinical registries presented
today at EuroPCR report positive clinical outcomes for one of
the most exciting emerging therapies in cardiology – transcatheter
aortic valve implantation for treatment of severe aortic stenosis.
The registries’ results demonstrate encouraging clinical outcomes
for more than 2,000 patients treated with the CoreValve percutaneous
aortic valve system from Medtronic, Inc. (NYSE: MDT). |
"We welcome the abundance of
positive data, which shows that transcatheter aortic valve therapy
is a successful treatment option for a patient population who
is at high risk or unable to undergo surgical valve replacement," said
Eberhard Grube, M.D., chief of the Division of Structural Heart
Disease, International Heart Center Rhein – Ruhr, Essen, Germany. "The
breadth and results of these post-market evaluations suggest
that CoreValve is successfully transitioning into general clinical
practice. It also shows that patient outcomes largely transcend
physician specialties, countries and clinical settings."
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Eberhard
Grube, MD |
Data presented during the “TAVI Facts, Figures and National Registries” session included findings from registries in Belgium, France, Germany, Italy and the United Kingdom. Overall the results demonstrate sustained positive patient outcomes following the procedure – at
six months and, in some studies, at one year. These new data reaffirm
findings from previous clinical trials that demonstrate high procedure
success rates and positive clinical outcomes in patients who have
received the CoreValve system. The Italian Registry in particular, with more than 750 patients, provides a deeper look at the performance of CoreValve. There was a highly significant and long-term improvement in symptoms, including heart failure improvement with a reduction in New York Heart Association (NHYA) functional class in a majority of patients. In addition, all hemodynamic performance indicators improved, and left ventricle hypertrophy (excessive wall thickness) decreased six months after implant. “The overall results of the Italian Registry were quite impressive, indicating superb device performance and patient outcomes, as well as relatively low complication rates,” said Sonia Petronio, M.D., associate professor of Cardiology and Head of the Catheterization Lab of the Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. “We
were especially pleased to see early reduction in LV hypertrophy,
similar to what is seen with surgical aortic valve replacement.
These results suggest that CoreValve is not only a suitable
aortic replacement valve but may also improve the overall pumping
function of the heart.” The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the United States. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures. The
CoreValve system received CE (Conformité Européenne) Mark
in March 2007. It is not yet available in the United States
for clinical trial or commercial sale or use. Medtronic is committed to advancing the treatment of cardiovascular disease through collaboration with leading clinicians, researchers and scientists 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.
Source: Medtronic,
Inc.
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