First Implant of DuraHeart Left Ventricular Assist System Made in Japanese Clinical Trial
November 4, 2008 - Terumo Heart Inc. said the first DuraHeart Left Ventricular Assist System (LVAS) was implanted in October at the University of Tokyo Hospital 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 Corp. 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 is a U.S. subsidiary of Terumo Corp. with headquarters and manufacturing facilities in Ann Arbor, MI. The company’s focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corp., 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 U.S., and is CE marked in Europe.
For more information: www.terumoheart.com
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