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Temporary Artificial Heart Wins U.S. Approval
2 hours, 46 minutes ago Health - Reuters
By Lisa Richwine
WASHINGTON (Reuters) - The first artificial heart won U.S. approval 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.
Reuters Photo
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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.
The newly approved artificial heart should be reserved for only the sickest patients, the Food and Drug Administration (news - web sites) said. Those include people with irreversible failure of both ventricles who have not responded to other treatments and are eligible for transplants. About 100 people per year meet that definition, the FDA (news - web sites) said.
The temporary device helps revive people who are starting to develop failure of the kidney, liver and other organs, said Dr. Jack Copeland, chief of cardiovascular and thoracic surgery at the University of Arizona Sarver Heart Center.
Patients can walk and exercise with the implant, Copeland said. The attached console, about the size of a small washing machine, is on wheels, and SynCardia is developing a smaller version.
Complications include infections, which afflicted 72 percent of patients in SynCardia's study. About 25 percent developed a neurological problem such as a stroke.
Survival rates after getting a live heart transplant are similar between patients who had the temporary device and others who did not, SynCardia said.
Scientists have been trying for years to develop an artificial heart.
Another company, Abiomed Inc., is seeking approval for a fully implanted artificial heart for patients ineligible for a transplant.
The FDA said it was requiring SynCardia to conduct a follow-up study of patients treated with the device.
2 hours, 46 minutes ago Health - Reuters
By Lisa Richwine
WASHINGTON (Reuters) - The first artificial heart won U.S. approval 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.
Reuters Photo
Yahoo! Health
Have questions about your health?
Find answers here.
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.
The newly approved artificial heart should be reserved for only the sickest patients, the Food and Drug Administration (news - web sites) said. Those include people with irreversible failure of both ventricles who have not responded to other treatments and are eligible for transplants. About 100 people per year meet that definition, the FDA (news - web sites) said.
The temporary device helps revive people who are starting to develop failure of the kidney, liver and other organs, said Dr. Jack Copeland, chief of cardiovascular and thoracic surgery at the University of Arizona Sarver Heart Center.
Patients can walk and exercise with the implant, Copeland said. The attached console, about the size of a small washing machine, is on wheels, and SynCardia is developing a smaller version.
Complications include infections, which afflicted 72 percent of patients in SynCardia's study. About 25 percent developed a neurological problem such as a stroke.
Survival rates after getting a live heart transplant are similar between patients who had the temporary device and others who did not, SynCardia said.
Scientists have been trying for years to develop an artificial heart.
Another company, Abiomed Inc., is seeking approval for a fully implanted artificial heart for patients ineligible for a transplant.
The FDA said it was requiring SynCardia to conduct a follow-up study of patients treated with the device.
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