CAUTION The Companion Driver System is an investigational device. Limited by United States law to investigational use.
Some photographs in this 2006 Annual Report show CardioWest™ TAH-t patients in an out-of-hospital environment with a portable driver. These photographs were taken in Europe. SynCardia has a CE mark for use of this driver in Europe. This driver is not FDA approved for use in the U.S.
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