SynCardia Systems, Inc. (Tucson, Ariz.) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia temporary Total Artificial Heart is currently approved as a bridge to heart transplantation for people dying from end-stage heart failure affecting both sides of the heart (biventricular failure).
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the “World's 50 Most Innovative Companies” for “giving mobility to artificial heart recipients.” Weighing 13.5 pounds, the Freedom® portable driver is the world’s first wearable power supply for SynCardia’s Total Artificial Heart. In the U.S., it is the first portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
Specialties
70cc Total Artificial Heart – bridge to transplant, 70cc & 50cc Total Artificial Hearts for destination therapy + bridge to transplant under development, Hospital-based and portable drivers for powering the Total Artificial Heart
