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Healthcare Industry News:  DuraHeart 

Devices Cardiology

 News Release - October 21, 2008

Fifth DuraHeart(TM) U.S. Implant Marks Important Milestone in U.S. Pivotal Trial

ANN ARBOR, Mich., Oct. 21 -- (Healthcare Sales & Marketing Network) -- Terumo Heart, Inc. announced today that five patients have received the DuraHeart(TM) Left Ventricular Assist System (LVAS), marking an important early milestone in the U.S. Pivotal Trial. A team led by Dr. Francis Pagani performed the five implants at the University of Michigan Cardiovascular Center in Ann Arbor with three of the surgeries performed off-pump.

"We congratulate Dr. Pagani on conducting the first off-pump implants of DuraHeart in the world." said Chisato Nojiri, M.D., Ph.D., Chief Executive Officer of Terumo Heart, Inc. "There are unique aspects of the DuraHeart system that make it possible to perform the procedure off-pump if the surgeon chooses this approach." The off-pump implant procedure offers significant advantages including less operative bleeding and shortened time in surgery.

The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York will serve as the Co-Principal Investigator with Dr. Pagani.

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.

Source: Terumo Heart

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