ANN ARBOR, Mich., July 27 /PRNewswire/ -- Terumo Heart, Inc. today announced the 20th patient was successfully implanted with the DuraHeart(TM) Left Ventricular Assist System (LVAS) on July 19, 2005 at University of Vienna General Hospital, Vienna, Austria, completing the European Clinical Trial of the device.
The trial has involved a total of 20 patients; the first being implanted on January 15, 2004 at Bad Oeynhausen, the Principle Investigation site for the study in Germany. Additional sites participating in the clinical trial are German Heart Center DHZ - Berlin, University of Vienna, and LaPitie and Henri Mondor in Paris.
The clinical trial has been very successful in demonstrating the safety and performance of the DuraHeart LVAS in the treatment of end-stage left ventricular failure. To date, five patients have been supported for more than six months, two patients more than one year, and one patient more than sixteen months. Dr. Chisato Nojiri, CEO and Medical Director, Terumo Heart, Inc. said, "We are very encouraged by the results of this initial clinical study. The majority of the patients were discharged home and are back to near normal life. One patient out of two one-year survivors has been supported for more than sixteen months. We are confident that the DuraHeart LVAS has a significant potential for lifetime support." The company plans to receive CE approval in early 2006.
The DuraHeart LVAS is a third generation circulatory support device intended for providing long-term cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It is currently the only implantable Left Ventricular Assist System combining a centrifugal pump and magnetic levitation technologies. The DuraHeart LVAS is exclusively for clinical investigation in Europe. The product is not currently available in the U.S.
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.
Terumo Heart, Inc.CONTACT: Mark White, Marketing Manager of Terumo Heart, Inc., Ann Arbor,Michigan, direct telephone, +1-734-741-6262, ormark.white@terumomedical.com