The first patient fitted with a Carmat artificial heart in France has died.
The 76-year-old man, who has not been named, died 75 days after the operation in Paris.
The bioprosthetic device, made by French company Carmat, is designed to replace the real heart for up to five years.
It is intended to help patients who are in the advanced stages of heart failure.
At this late stage of the disease, the damaged organ can no longer pump enough blood for the body to function normally.
When the device was fitted, the patient was said to have only a few weeks, or even days to live.
It’s not known whether his death was due to any malfunction of the artificial heart or the patient’s severe ill-health.
Three more patients in France with terminal heart failure are scheduled to be fitted with the artificial heart.
The Carmat heart is designed to work for five years
The clinical trial will be considered a success if they survive for at least a month.
A further trial of another 20 patients will examine to what extent the device improves their quality of life.
Eventually the company hopes to get a European license for the prototype heart, which is expected to cost around $240,000.
The Carmat device weighs nearly 2 pounds, three times that of a human heart. It is powered by an external lithium battery pack, which the patient wears on a belt.
It is made from a combination of synthetic materials, surrounded by a plastic shell.
Inside the heart, some of the surfaces which come into contact with blood are made from cow heart tissue, which are less likely to cause clots to form.
The patient trials follow many years of laboratory research and extensive animal studies.
The Carmat heart is designed to work for five years.
Artificial hearts have been used for decades, but usually as a means of helping a failing heart to pump blood around the body.
Several companies are working on devices which entirely take over from the damaged organ until a donor heart becomes available.
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Jakub Halik, a Czech father of one who survived for more than six months without a real heart, has died at the age of 37.
Jakub Halik had his heart replaced with two mechanical pumps in pioneering surgery last April after an aggressive cancerous tumor was found.
Doctors say his death was caused by liver failure, and not the artificial heart itself.
Jakub Halik, a former firefighter, was waiting on the transplant list for a suitable donor when he died.
Despite not having a pulse and always having to carry a battery pack to power his mechanical heart, Jakub Halik was able to walk around and even use the hospital gym.
He was not able to accept a donor heart earlier because the cancer meant he would not be able to take the drugs he would need for a successful organ transplant.
The radical surgery had only ever been tried on one other patient, a man in Texas, who survived for just a week.
Jakub Halik had his heart replaced with two mechanical pumps in pioneering surgery last April after an aggressive cancerous tumor was found
Jakub Halik’s operation was carried out by Jan Pirk, director of cardiology at the Institute of Clinical and Experimental Medicine in Prague.
His team used two plastic pumps, each designed to perform the separate tasks of the left and right sides of the heart.
Speaking at a press conference in August more than four months after the surgery, Jakub Halik said he felt “very good physically”, and said he had made the right choice to proceed with the operation.
“It was hard for me but I didn’t have any other chance at all,” he told reporters.
“It was acknowledged that with the tumor I can survive for about one year and I decided to fight and do it this way.”
He said the experience of living without a heart had not been difficult.
“I don’t even realize it, because the functions of the body are the same, only my heart is not beating and I have no pulse anymore,” Jakub Halik said.
“Otherwise I am functioning like a healthy man at present.”
Doctors said it is unclear how Jakub Halik’s liver failed. They are awaiting the outcome of a post-mortem examination.