Terumo Heart Obtains IRB Approval From The University Of Michigan To Initiate DuraHeart(TM) Left Ventricular Assist System U.S. Pivotal Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Transplants / Organ Donations;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 26 Jun 2008 - 2:00 PDT

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Terumo Heart, Inc. announced approval from the Institutional Review Board (IRB) at the University of Michigan to move forward with the DuraHeart(TM) Left Ventricular Assist System (LVAS) U.S. Pivotal Trial for a Bridge to Transplant (BTT) indication. Francis Pagani, M.D., Ph.D., Director of the Adult Heart Transplantation and Artificial Devices Program at the University of Michigan, will serve as the National Co-Principal Investigator of the U.S. Pivotal Trial.

The University of Michigan IRB approval is the final step to initiate the DuraHeart LVAS U.S. Pivotal Trial following the completion of staff training and equipment delivery. The University of Michigan also serves as the primary training site for the U.S. Trial.

Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said, "With the IRB approval, DuraHeart LVAS will be the first third-generation centrifugal pump with magnetic levitation under investigation in the U.S. We look forward to working with Dr. Pagani and his team on the U.S. Pivotal Trial."

The DuraHeart LVAS Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York, will serve as the National Co-Principal Investigator with Dr. Pagani.

The DuraHeart LVAS is a third-generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It is currently the only CE marked implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing exceptional reliability and minimizing the potential for blood damage and thrombus. The DuraHeart LVAS is not available for sale in the United States.

Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products.

Terumo Heart, Inc.
http://www.terumoheart.com

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