First U.S. Clinical Trial Implant of DuraHeart LVAS Performed


August 7, 2008

August 6, 2008 - The first U.S. implant of Terumo Heart Inc.’s DuraHeart Left Ventricular Assist System (LVAS) took place on July 30 at the University of Michigan Cardiovascular Center in Ann Arbor.

National Co-Principal Investigator for the DuraHeart U.S. Pivotal Trial, Francis Pagani, M.D., Ph.D., performed the surgery. DuraHeart is reportedly the world's first third-generation LVAS 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.

The U.S. patient represents the 71st patient worldwide since the DuraHeart European investigational trials began in 2004, according to Terumo. 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 multicenter, 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.

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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