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www.fdanews.com/articles/91792-syncardia-systems-focuses-on-first-temporary-artificial-heart

SynCardia Systems Focuses on First Temporary Artificial Heart

March 22, 2007

SynCardia Systems announced it recruited five leading biomedical scientists and physicians to review its temporary total artificial heart -- the world's first -- and help keep the device "state-of-the-art," the company said.

The device was originally designed as a permanent replacement heart. The CardioWest, in its current function, has been studied and used for nearly 20 years, SynCardia said. The FDA and CE Mark indication for the device is as a bridge to transplant.

The announcement cited a clinical study published in the New England Journal of Medicine showing the one-year survival rate for patients receiving the CardioWest was 70 percent, compared with 31 percent for patients who did not receive the device.