In 2004, the United States Food and Drug Administration (FDA) approved the first implantable temporary artificial heart, which keeps heart failure patients alive until they can receive a transplant.
A direct descendant of the Jarvik-7, implanted into dentist Barney Clark in 1982, the CardioWest Total Artificial Heart takes over a patient’s failing ventricles, the heart’s lower two pumping chambers and all cardiac valves. Manufactured by Syncardia Systems Inc., of Tucson, Ariz., the device is a “bridge” for people waiting for a heart transplant who do not respond to other treatments and who are at risk of imminent death from non-reversible bi-ventricular failure (left and right side heart failure).
The FDA approval was based in large part on the results of a study of the artificial heart in 81 patients at high risk for death due to irreversible biventricular cardiac failure. The rate of survival to transplantation was 79 percent, compared with 46 percent in a group of control patients who did not receive the artificial heart. The one-year survival rate among patients who received the artificial heart was 70 percent, compared with 31 percent among the controls. The one and five year survival rates among transplant recipients were 86 percent and 64 percent.
In 2006, the FDA approved first totally implanted permanent artificial heart for patients with advanced heart failure involving both pumping chambers of the heart. According to the FDA, the "AbioCor Implantable Replacement Heart, made by Abiomed, Inc. (Danvers, Mass.), is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention."
A direct descendant of the Jarvik-7, implanted into dentist Barney Clark in 1982, the CardioWest Total Artificial Heart takes over a patient’s failing ventricles, the heart’s lower two pumping chambers and all cardiac valves. Manufactured by Syncardia Systems Inc., of Tucson, Ariz., the device is a “bridge” for people waiting for a heart transplant who do not respond to other treatments and who are at risk of imminent death from non-reversible bi-ventricular failure (left and right side heart failure).
The FDA approval was based in large part on the results of a study of the artificial heart in 81 patients at high risk for death due to irreversible biventricular cardiac failure. The rate of survival to transplantation was 79 percent, compared with 46 percent in a group of control patients who did not receive the artificial heart. The one-year survival rate among patients who received the artificial heart was 70 percent, compared with 31 percent among the controls. The one and five year survival rates among transplant recipients were 86 percent and 64 percent.
In 2006, the FDA approved first totally implanted permanent artificial heart for patients with advanced heart failure involving both pumping chambers of the heart. According to the FDA, the "AbioCor Implantable Replacement Heart, made by Abiomed, Inc. (Danvers, Mass.), is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention."
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