2007 Annual Report

2007cover

CAUTION
The Companion Driver System is an investigational device, limited by United States law to investigational use.

10cc & 30cc VAD prototypes, 50cc TAH-t prototype and Companion II Driver prototype are not for human use. These products are in the research and development phase and will not be available for sale in the United States or Europe until after all regulatory requirements have been met.

The portable driver is CE approved for use in Europe. It is not FDA approved for use in the U.S.

 

To continue, click below if you agree with the above statement:

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*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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