Fifth DuraHeart U.S. Implant Marks Milestone in U.S. Pivotal Trial


October 21, 2008

October 21, 2008 - Terumo Heart Inc. said today five patients have received the DuraHeart Left Ventricular Assist System (LVAS), marking an important early milestone in the U.S. Pivotal Trial.

A team led by Francis Pagani, M.D., performed the five implants at the University of Michigan Cardiovascular Center in Ann Arbor with three of the surgeries performed off-pump. These were the first off-pump implants of DuraHeart in the world. The company said there are unique aspects of the DuraHeart system that make it possible to perform the procedure off-pump. 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.

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