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.
Terumo Heart, Inc.
terumoheart
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