October 28, 2008
First Implant Terumo’s Left Ventricular Assist System (LVAS)
in Japanese Clinical Trial
Terumo Corporation announced that Terumo’s Left Ventricular Assist System (LVAS) was first implanted in October at the University of Tokyo Hospital. 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.”
(Note) Forward-looking statements included in this release were determined by Terumo based on the best information available at the time of writing and are subject to potential risks and uncertainties. Therefore, please note that, due to various factors, the actual implementation may differ from what is described here.