Healthcare Industry News:  DuraHeart 

Devices Cardiology Regulatory

 News Release - February 27, 2007

Terumo Heart Inc. Receives CE Mark for Left Ventricular Assist System in Europe

ANN ARBOR, Mich., Feb. 27 (HSMN NewsFeed) -- Terumo Heart Inc. announced today that it has received a CE Mark allowing the commercial distribution of the DuraHeart Left Ventricular Assist System within the European Community. The DuraHeart is the world's first magnetically levitated centrifugal LVAS to receive market approval in Europe.

The CE Mark approval is based on a clinical trial conducted in four European centers (Germany, Austria, and France). The cumulative duration of patient support is greater than 5000 days, with the longest being more than 600 days. Twelve patients were supported for more than 6 months and 4 for more than 1 year. The overall success rate was 79%. To date 33 patients have been implanted with the device.

Chisato Nojiri, M.D., Ph.D., CEO & Medical Director for Terumo Heart Inc. said, "The CE Mark was granted after rigorous review of the design, manufacturing, quality, and clinical data of the DuraHeart LVAS. We are very pleased with the clinical trial results and performance of the device. After commencing with the EU market launch, we will be moving towards the US IDE Clinical Trial based on the confidence gained from the clinical experience in Europe."

The DuraHeart LVAS is a 3rd 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 approved implantable Left Ventricular Assist System combining a centrifugal pump with magnetic levitation of the impeller, ultimately providing adequate physiologic response and minimizing the potential for blood damage and thrombus.

Terumo Heart Inc. is a wholly owned 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.


Source: Terumo

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