SynCardia Systems, Inc.: manufactures the world's first and only approved Total Artificial Heart
To provide Bridge to Life technologies for patients dying from heart failure. This chronic and progressive disease claims the lives of hundreds of thousands each year. The numbers are staggering and we take our responsibility seriously.
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been nearly 1,300 implants of the Total Artificial Heart, accounting for more than 350 patient years of life.
The Freedom® portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
CAUTION - The Freedom portable driver is an investigational device, limited by United States law to investigational use.