Healthcare Industry News: DuraHeart
News Release - October 21, 2008
Fifth DuraHeart(TM) U.S. Implant Marks Important Milestone in U.S. Pivotal TrialANN ARBOR, Mich., Oct. 21 -- (Healthcare Sales & Marketing Network) -- Terumo Heart, Inc. announced today that five patients have received the DuraHeart(TM) Left Ventricular Assist System (LVAS), marking an important early milestone in the U.S. Pivotal Trial. A team led by Dr. Francis Pagani performed the five implants at the University of Michigan Cardiovascular Center in Ann Arbor with three of the surgeries performed off-pump.
The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York will serve as the Co-Principal Investigator with Dr. Pagani.
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. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe.
Source: Terumo Heart
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