The first artificial heart won U.S. approval on Monday for use as a temporary measure to keep alive patients on the verge of death while they wait for live organs to become available for transplants. The CardioWest Total Artificial Heart, made by privately held SynCardia Systems Inc., replaces the left and right ventricles, the heart's lower pumping chambers. Surgeons sew the device to the upper chambers. The implanted heart must be used in hospitals because patients need to be connected to a computerized console to regulate blood flow. The device costs up to $100,000. SynCardia's implant will offer an alternative to gravely ill patients with less than 30 days to live. The wait for a donated heart can stretch for months. About 4,000 U.S. patients await heart transplants each year, and only about 2,200 donor hearts typically become available. Mechanical pumps called left ventricular assist devices can help but often cannot maintain full heart function. Between 30 percent and 40 percent of patients with an assist device die before transplant. In a SynCardia study of 81 patients, mostly men, who got the implanted heart, 79 percent stayed alive long enough to get a transplant -- an average of 79 days. --More 2139 Local Time 1839 GMT
