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. In the United States, the CoreValve System is currently limited to investigational use.
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."