ANN ARBOR, Mich., Aug. 6 /EMWNews/ -- Terumo Heart, Inc. announced

that the first U.S. implant of the DuraHeart(TM) Left Ventricular Assist

System (LVAS) took place on July 30 at the University of Michigan

Cardiovascular Center in Ann Arbor, Michigan. The surgery was performed by

Francis Pagani, M.D., Ph.D. National Co-Principal Investigator for the

DuraHeart U.S. Pivotal Trial. DuraHeart is the world's first third

generation left ventricular assist system combining a centrifugal pump with

a magnetically levitated impeller to enter clinical trials in the U.S.



    "The DuraHeart gives us a new, third-generation option for patients

with advanced heart failure who need help to allow them to survive until

they can receive a heart transplant," says Pagani, who leads the U-M Center

for Circulatory Support.



    Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart,

Inc., said, "The first patient in the United States is an important initial

step in the pivotal trial. This patient is the 71st patient worldwide since

the DuraHeart European investigational trials began in 2004. We have had

exceptional outcomes in Europe and look forward to similar outcomes in the

U.S." In clinical results as of July 31, 2008, patient support averaged 223

days with cumulative support of 43 years. The longest ongoing patient

support is over three years.



    The DuraHeart LVAS 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 heart

failure. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital

in New York, will serve as the National Co-Principal Investigator with Dr.

Pagani.



    Dr. Nojiri added, "We are excited at the prospect of making this state

of the art technology readily available for the increasing need of heart

failure patients. Third generation systems are anticipated to demonstrate

improved outcomes and long term reliability. DuraHeart is the most advanced

third generation centrifugal pump by virtue of the magnetically levitated

impeller, positioning us for a leadership role in the future treatment of

heart failure." In addition to the U.S. trial, Terumo Heart is expected to

initiate clinical trials in Japan this year.



    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,

headquartered 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.



    http://www.terumoheart.com/