Sunday, November 14, 2004

Artificial Heart Systems Receive FDA Green Light

Artificial Heart Systems Receive FDA Green Light

Tucson, Ariz. — The CardioWest Temporary Total Artificial Heart came off the U.S. Food and Drug Administration’s “experimental list” Oct. 18, capping 19 years of development at the University of Arizona and a nine-year study of the device as a “bridge to transplant.”

The CardioWest is an air-driven device that is placed in the chest, replacing the ventricles and all four heart valves, and has an external control console. Compared with other artificial heart systems, including the Jarvik-7 from which it evolved, the device has the shortest blood path and exposure to artificial surfaces, which reduces the risk of infection and clots, and pumps the most blood with each heartbeat.

A nine-year study of the CardioWest showed that recipients become better candidates for eventual transplantation. The results, published in the New England Journal of Medicine in August, showed that CardioWest recipients had a one-year survival rate of 70%, compared with 31% for patients in the study who did not receive the artificial heart.

That 1993-2002 study involved the University of Arizona Medical Center; Loyola Medical Center in Chicago; LDS Hospital in Salt Lake City; Saint Luke’s Medical Center in Milwaukee; and the University of Pittsburgh Medical Center.