Medtronic has implanted the first patient with its CoreValve system in a clinical trial in Japan.
The trial will evaluate the safety and effectiveness of the Medtronic CoreValve system in patients with symptomatic, severe aortic stenosis who are at high risk or are ineligible for open-heart surgery.
The trial is being led by Professor Yoshiki Sawa at Osaka University Hospital.
The company also received Korea Food & Drug Administration approval for its CoreValve system last month.
Medtronic vice-president John Liddicoat said the successful results from the Japanese and Korean trials form the key steps for the transcatheter valve therapies to patients suffering from severe aortic stenosis.