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First Implant of DuraHeart(TM) Left Ventricular Assist System (LVAS) in Japanese Clinical Trial
Date:10/31/2008

ANN ARBOR, Mich., Oct. 31 /PRNewswire/ -- Terumo Heart Inc. announced that the first DuraHeart(TM) Left Ventricular Assist System (LVAS) was implanted in October at the University of Tokyo Hospital in Japan. Terumo Corporation will continue efforts toward an early application for approval for manufacture and sales in Japan.

Terumo's LVAS is the world's first third generation left ventricular assist system combining a centrifugal pump with a magnetically levitated impeller. The product received the CE mark in Europe in 2007 and began its U.S. Pivotal Trial in July 2008.

The "Mag-Lev" centrifugal pump technology was developed by Dr. Akamatsu, former professor of the Faculty of Engineering, Kyoto University in collaboration with NTN Corporation. The development base was moved to the U.S. in 2000 to continue product realization and commercialization.

In Japan, the Ministry of Health, Labor and Welfare highlighted implantable left ventricular assist devices in the "Council Regarding Early Introduction of Medical Equipment with Medical Needs."

Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe.


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SOURCE Terumo Heart, Inc.
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