The CardioWest artificial heart, developed by Tucson’s University Medical Center, has been used commercially for the first time in the United States.
The Cleveland Clinic implanted a CardioWest Temporary Total Artificial Heart about a week ago in a dying man in his ’40s, less than one year after the CardioWest became the first artificial heart approved by the Food and Drug Administration.
Although UMC and other hospitals in the United States and Europe have implanted more than 30 artificial hearts in patients, the Cleveland Clinic is the first hospital that was not involved in the research to implant the device.
“This represents the kickoff of the American commercialization of this technology,” Dr. Marvin Slepian, a University of Arizona cardiologist and president and of SynCardia Systems Inc., told the Arizona Daily Star.
SynCardia is the privately held company started in 2001 to manufacture and market the artificial heart. According to the Star, the listed retail price for the device is $100,000, and SynCardia is required by the FDA to train a center before the device can be used on a patient.
Less than one year ago, the heart became the first of its kind to win approval by the FDA for use in patients facing imminent death due to failure on both sides of the heart. It is only approved in the United States for use as a “bridge”–a temporary measure until a patient can get a real heart transplant. Independent health centers have begun trying to use the heart as a permanent replacement.
The CardioWest artificial heart evolved from the Jarvik-7 total artificial heart, which in December 1982 kept Barney Clark of Seattle alive at the University of Utah for 112 days.
In 1985, Dr. Robert Jarvik began collaborating with Dr. Jack Copeland, head of UMC’s artificial heart and heart and lung transplant programs. That year Copeland became the first surgeon in the world to use the artificial heart as a successful bridge. In 1991, University Medical Center and MedForte Research Foundation created CardioWest Technologies Inc. and the device’s technology was transferred to the new company.
UMC invested about $10 million in the device to keep it available to patients on a research basis prior to SynCardia’s founding four years ago.
Prior to receiving FDA approval, the artificial heart underwent a nine year study. The results, which were published in The New England Journal of Medicine in Aug. 2004, showed that those who received the CardioWest had a one-year survival rate of 70 percent, compared with 31 percent for patients in the study who did not receive the artificial heart.
Earlier this year the American Heart Association honored the CardioWest total artificial heart as the top advance of 2004.
For more information:
“ Giant step for UMC-born heart,” Arizona Daily Star, 08/02/2005
“CardioWest Named Top Advance for 2004 by American Heart Association,” University of Arizona Health Sciences Center press release, 01/21/2005
“CardioWest Total Artificial Heart Wins Approval from FDA,” UAHSC press release, 10/18/2004