First DuraHeart Left Ventricular Assist System Implanted in the U.S. Trial


August 7, 2008

August 7, 2008 - Terumo Heart Inc. yesterday said the first U.S. implant of the DuraHeart Left Ventricular Assist System (LVAS) took place July 30 at the University of Michigan Cardiovascular Center in Ann Arbor.

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,” said Dr. Pagani, who leads the U-M Center for Circulatory Support.

This patient is the 71st patient to get the implant worldwide since the DuraHeart European investigational trials began in 2004. In clinical results as of July 31, 2008, patient support averaged 223 days. The longest ongoing patient support is more than 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.

“We are excited at the prospect of making this state of the art technology readily available for the increasing need of heart failure patients,” Dr. Nojiri said. “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. DuraHeart is limited to investigational use only in the U.S., and is CE marked in Europe.

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