SynCardia Systems Inc., Tucson, Ariz., has received U.S. Food and Drug Administration (FDA) approval to conduct a clinical study of the effectiveness of the SynCardia temporary Total Artificial Heart for permanent use, also called destination therapy. The FDA approved the SynCardia Investigational Device Exemption (IDE) application in December to conduct the study in 19 patients who do not qualify for a donor heart transplant.
“The SynCardia Total Artificial Heart is already FDA-approved as a bridge to a donor heart transplant.” says Michael P. Garippa, president and CEO of SynCardia Systems Inc. “This is an important step for SynCardia to advance the use of the Total Artificial Heart to a new group of patients who are not currently eligible for a donor heart.”
Clinically stable patients implanted with the device will receive the FDA-approved Freedom® portable driver, which powers the SynCardia Heart and allows patients increased mobility. The high volume of blood flow provided , combined with the mobility offered by the Freedom portable driver, is designed to allow patients who were once near death to enjoy a full life at home and in their communities.
The device is implanted in patients who are dying of end-stage biventricular heart failure in which the two ventricles of the native heart cannot pump enough blood for the patient to survive. Similar to a donor heart transplant, it replaces the native heart’s two failed ventricles and four valves. It is the only approved device that eliminates the source of end-stage biventricular heart failure.
Because of the growing demand for donor hearts, and the flat supply, many patients live for months or years supported by the SynCardia Total Artificial Heart. The longest a person has lived the device was nearly four years before his donor heart was successfully transplanted. Materials used in the device include polyurethane, graphite, Dacron mesh and others.