SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. The company was formed in 2001 by world-renowned heart surgeon Jack G. Copeland, MD, interventional cardiologist Marvin J. Slepian, MD, and biomedical engineer Richard G. Smith, MSEE, CCE, to commercialize the SynCardia temporary Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for patients suffering from end-stage heart failure affecting both sides of their heart (biventricular failure).
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers.
During the 10-year pivotal clinical study which resulted in FDA approval, 79% of near-death patients who received the Total Artificial Heart were bridged to transplant. This is the highest bridge-to-transplant rate of any approved device in the world.