Terumo Heart, Inc. today announced the discharge of the first U.S. patient implanted with the DuraHeart(TM) Left Ventricular Assist System (LVAS). The patient was discharged home on August 14th, from the University of Michigan Health System, 15 days after receiving the device.
The patient is a 62-year-old man from Livonia, Michigan, who has been suffering from heart failure for nearly 20 years. He is the first U.S. patient to receive a ventricular assist system that utilizes advanced magnetic levitation (Mag-Lev), a new, innovative type of technology.
Dr Pagani, National Co-Principal Investigator for the U.S. pivotal trial of the DuraHeart LVAS commented on the recent discharge. "We are extremely pleased with the performance of the DuraHeart and the recovery of our patient to an excellent functional state to permit discharge. We look forward to expanding upon our early experience with the DuraHeart in the near future."
The goal of these devices is to return the patient back to a relatively normal lifestyle and to provide improved "quality of life." "We are delighted that the FDA has allowed us to begin this trial with no restriction on patient discharge, which has not been true of some of the other devices currently conducting Trials in the United States," said Chisato Nojiri, M.D., PhD, Chief Executive 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 in the DuraHeart LVAS to potentially overcome these problems. Dr. Nojiri explained: "We have a unique pump design that combines advanced "Mag-Lev" technology and a centrifugal pump. The "Mag-Lev" allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy." It has been used in more than 70 patients in Europe with the longest ongoing support over 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 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. The National Co-Principal Investigators are Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.
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