Discharge of First U.S. DuraHeart(TM) Patient

Thursday, August 21, 2008 General News
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ANN ARBOR, Mich., Aug. 21 /PRNewswire/ Terumo Heart, Inc. today announcedthe discharge of the first U.S. patient implanted with the DuraHeart(TM) LeftVentricular Assist System (LVAS). The patient was discharged home on August14th, from the University of Michigan Health System, 15 days after receivingthe device.

The patient is a 62-year-old man from Livonia, Michigan, who has beensuffering from heart failure for nearly 20 years. He is the first U.S.patient to receive a ventricular assist system that utilizes advanced magneticlevitation (Mag-Lev), a new, innovative type of technology.

Dr Pagani, National Co-Principal Investigator for the U.S. pivotal trialof the DuraHeart LVAS commented on the recent discharge. "We are extremelypleased with the performance of the DuraHeart and the recovery of our patientto an excellent functional state to permit discharge. We look forward toexpanding upon our early experience with the DuraHeart in the near future."

The goal of these devices is to return the patient back to a relativelynormal lifestyle and to provide improved "quality of life." "We are delightedthat the FDA has allowed us to begin this trial with no restriction on patientdischarge, which has not been true of some of the other devices currentlyconducting Trials in the United States," said Chisato Nojiri, M.D., PhD, ChiefExecutive Officer for Terumo Heart, Inc.

Earlier generation Left Ventricular Assist devices are prone to hemolysis,blood clots and mechanical failure. Significant advances have been made inthe DuraHeart LVAS to potentially overcome these problems. Dr. Nojiriexplained: "We have a unique pump design that combines advanced "Mag-Lev"technology and a centrifugal pump. The "Mag-Lev" allows for the completeelimination of mechanical contact within the blood flow path, minimizing thechance of mechanical failure. This is expected to significantly improve theclinical performance and long-term potential of this type of therapy." It hasbeen used in more than 70 patients in Europe with the longest ongoing supportover 3 years.

The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center,prospective, non-randomized study of 140 patients and will include up to 40centers. The device is intended to provide cardiac support for patientsawaiting transplant who are at risk of death due to end-stage left ventricularfailure. The National Co-Principal Investigators are Francis Pagani, M.D.,Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., fromColumbia Presbyterian Hospital in New York.

Terumo Heart, Inc. is a US subsidiary of Terumo Corporation withheadquarters and manufacturing facilities in Ann Arbor, Michigan. Thecompany's focus is the innovation and introduction of products to improve thequality of healthcare for heart failure patients. Terumo Corporation, locatedin Tokyo, Japan, is a leading developer, manufacturer and global marketer of awide array of medical products.

For more information, please contact Carmen Fox, Senior MarketingCommunications Specialist, Terumo Heart, Inc. at (734) 741-6345 orcarmen.fox@terumomedical.com.

SOURCE Terumo Heart, Inc.

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