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Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient
Date:3/9/2009

ANN ARBOR, Mich., March 9 /PRNewswire/ -- Terumo Heart, Inc. today announced that NewYork-Presbyterian Hospital/Columbia University Medical Center recently became the second U.S. center, and first in the Northeast, to implant the DuraHeart(TM) Left-Ventricular Assist System as part of the DuraHeart Bridge-To-Transplant U.S. pivotal trial, a multi-center, prospective, non-randomized study, involving 140 patients in up to 40 centers nationwide. The trial will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-state left ventricular failure.

The medical team led by Yoshifumi Naka, M.D., Ph.D., director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons, elected to implant the DuraHeart(TM) System using an "off-pump" procedure, allowing him to operate directly on the beating heart, thus reducing the risk for perioperative bleeding and stroke associated with having a patient on bypass.

"We are pleased to be a part of this landmark trial evaluating this third-generation mechanical heart pump, one of the first of its kind to enter clinical trials in the U.S.," said Dr. Naka, who serves as co-principal investigator of the DuraHeart Trial.

"It is extremely gratifying for us to count Dr. Naka's team among those elite institutions who are investigating Terumo Heart's DuraHeart System and building the empirical body of evidence to support the eventual U.S. approval of this important device," said Chisato Nojiri, M.D., Ph.D., Chairperson and Chief Medical Officer, Terumo Heart, Inc. "As a company, we are committed to investing in the resources that will ultimately deliver the most advanced left-ventricular assist device available to help patients retain a healthy
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SOURCE Terumo Heart Inc.
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