First U.S. DuraHeart Patient Goes Home


August 21, 2008

August 21, 2008 – The first U.S. patient implanted with the DuraHeart Left Ventricular Assist System (LVAS) was discharged home 15 days after receiving the device, Terumo Heart Inc. announced today.

The 62-year-old male patient left the University of Michigan Health System on August 14. Suffering from heart failure for nearly 20 years, he is the first U.S. patient to receive a ventricular assist system that utilizes advanced magnetic levitation (Mag-Lev), a new, innovative type of technology.

Francis Pagani, M.D., Ph.D, national co-principal investigator for the U.S. pivotal trial of the DuraHeart LVAS commented on the recent discharge. "We are extremely pleased with the performance of the DuraHeart and the recovery of our patient to an excellent functional state to permit discharge. We look forward to expanding upon our early experience with the DuraHeart in the near future."

Earlier generation left ventricular assist devices are prone to hemolysis, blood clots and mechanical failure. Significant advances have reportedly been made in the DuraHeart LVAS to potentially overcome these problems.

"We have a unique pump design that combines advanced "Mag-Lev" technology and a centrifugal pump. The "Mag-Lev" allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy," explained Chisato Nojiri, M.D., PhD, chief executive officer for Terumo.

The DuraHeart Bridge-to-Transplant 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 failure. The National Co-Principal Investigators are Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.

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