Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failur...(of bleeding complication rose with age w...),Health

Date:4/7/2009

of bleeding complication rose with age, with a likely cause being excessive anticoagulation/anti-platelet regimen. The investigators agreed to follow a less intensive aniticoagulation/anti-platelet regimen, which resulted in significantly improved results (neurological dysfunction: 0.23 per patient-year with no incident of CVA (Cerebrovascular Accident)) for the remainder of the study.

"Our European experience paved the way for our U.S. clinical trial, serving as a highly positive and important beginning to our plans for a broader global introduction of this much-needed technology," said Chisato Nojiri, M.D., Ph.D., Chairperson of the Board & Chief Medical Officer for Terumo Heart. "We have invested significant resources to ensure the design, quality, manufacturing, and critical scientific evidence behind DuraHeart. We greatly appreciate the confidence and support we have from physicians in Europe and in our clinical trials to entrust their patients to DuraHeart."

About the DuraHeart System

The DuraHeart System is the first third-generation rotary blood pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear. The DuraHeart System carries a CE Mark and is currently available for sale outside of the United States. The pivotal U.S. Bridget to Transplant DuraHeart Trial, involving up to 40 clinical sites and 140 patients is in process. The company has completed trial enrollment for this device in Japan. The DuraHeart System features a small pump that is implanted in a pocket created in the abdomen. When the pump is activated, the impeller position is precisely controlled by the electromagnets and sensors to keep it centered within the blood chamber. Permanent magnets couple the impeller to the motor so when the mot
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SOURCE Terumo Heart, Inc. Copyright©2009 PR Newswire. All rights reserved

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