December 8, 2010
Terumo's Implantable Left Ventricular Assist System "DuraHeart" obtains the Manufacture and Sales Approval by the Ministry of Health, Labor and Welfare in Japan.
Terumo Corporation (Head office: Shibuya-ku, Tokyo; President: Yutaro Shintaku) announced that the implantable left ventricular assist system "DuraHeart" has obtained the manufacture and sales approval by the Ministry of Health, Labor and Welfare in Japan.
Terumo's Left Ventricular Assist System "DuraHeart" employs a "Magnetic Levitation centrifugal pump" where a magnetically levitated impeller rotates and pumps the blood while minimizing previously known damages to blood.
In Japan, Terumo's clinical trial began in April 2008, and Terumo applied for manufacture and sales approval by the Japanese Ministry of Health, Labor and Welfare, in September 2009. It was launched in the Europe in 2007, and began clinical trials in the U.S. in July 2008.
Terumo's Left Ventricular Assist System was jointly developed by Professor. Teruaki Akamatsu, from the Faculty of Engineering in the Kyoto University, in collaboration with NTN Corporation. The joint program began in 1994.
In Japan, the Ministry of Health, Labor and Welfare chose "Implant Type Left Ventricular Assist Devices" as a theme subject to "Council Regarding Early Introduction of Medical Equipment with Medical Needs" and Terumo's Left Ventricular Assist System has been selected as an appropriate device.
Terumo's Left Ventricular Assist System has been specified as the medical device for orphan disease by the Ministry of Health, Labor and Welfare in Japan.
Corporate Communication Dept., Terumo Corporation
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