Ann Arbor-based Terumo Heart Inc. announced Tuesday that five patients have received the DuraHeart Left Ventricular Assist System, 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.
"We congratulate Dr. Pagani on conducting the first off-pump implants of DuraHeart in the world." said Chisato Nojiri, M.D., Ph.D., Terumo Heart CEO. "There are unique aspects of the DuraHeart system that make it possible to perform the procedure off-pump if the surgeon chooses this approach."
The off-pump implant procedure offers significant advantages including less operative bleeding and shortened time in surgery.
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 is a United States subsidiary of Japan's Terumo Corp. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe.
More at www.terumoheart.com.
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