MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE:
MDT) today announced the first implant in a clinical trial in Japan that will
evaluate the safety and effectiveness of the Medtronic CoreValve® System.
The successful procedure in the trial was led by Professor
Yoshiki Sawa of the Department of Cardiovascular Surgery at Osaka University
Hospital. “With the
number of aortic valve stenosis patients steadily rising as the Japanese
population ages, we consider this an important step towards the introduction of
a new therapeutic option to the healthcare system,” said Professor Sawa.
The CoreValve System provides a minimally invasive treatment
option for patients with symptomatic, severe aortic stenosis who are at high
risk, or are ineligible, for open-heart surgery. Worldwide, approximately
300,000 people have been diagnosed with this condition, and approximately
one-third of these patients are deemed at too high a risk for open-heart
surgery.1 In the United States, the CoreValve System is currently limited to investigational
Medtronic also received approval from the Korea Food &
Drug Administration (KFDA) for the CoreValve System in October.
Recently, first implants of the CoreValve System took place
in Thailand and Singapore (January 2011), China and Hong Kong (December 2010), and Taiwan
(September 2010). Worldwide, the Medtronic CoreValve System has been implanted
in more than 20,000 patients in more than 50 countries. The Medtronic CoreValve
System first was approved in Europe in 2007.
“Medtronic is the global leader in medical device
innovation, bringing an unmatched breadth of novel therapies to treat patients
with heart disease,” said John Liddicoat, senior vice president, Medtronic, and
president of Medtronic Structural Heart. “These successes in Japan and Korea are important steps in
bringing forward our revolutionary, transcatheter valve therapies to patients
around the world who suffer from severe aortic stenosis.”
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 Medtronics periodic reports on file
with the Securities and Exchange Commission. Actual results may differ
materially from anticipated results.
1 Decision-making in elderly patients with severe aortic
stenosis: why are so many denied surgery? Bernard Iung et al. Eur Heart
J (December 2005) 26(24): 2714-2720.