FDA refused to recommend the use of AbioCor total artificial heart – the heart, medical equipment, medical equipment – HC Network Medical Device Industry
If your heart can not make you get through this month, if you do not have other methods of treatment, if you would very much like to read the world slower to catch, are you willing to accept a fully artificial heart. U.S. Food and Drug Administration (FDA) scientists in the 23 through the intense discussion, very difficult to make a choice: they refused to recommend the use of this totally artificial heart.
By the Abiomed's AbioCor artificial heart company has been in the 14 patients were also tested. 2 of which died in the operating table, the rest will live an average of 5 months or so, but about half of them in the final years of illness suffered relentless torture, some of which even in loss of brain function in most cases, spend the last years. Only one patient is lucky, his success to live for 17 months, and finally died due to wear artificial heart. His family told the FDA officials in the heart with their extension of time is priceless.
But FDA scientists to consider is: Is it worth risking the danger of under great pain to extend the time. Scientists disagree. From the University of Texas Dr. ClydeYancey not worth the risk, while those from Columbia University, Dr. JudahWeinberger this gives rise to hope, hope is priceless.
FDA scientists usually follow the recommendation, but this has yet to be conclusive. FDA's Executive JulieSwain said: "This is really a hard choice." She hopes to extend the AbioCor artificial heart in human life, not extend the time for people to die.
AbioCor artificial heart different from previous products is that it is a mechanical Heart Do not need a cable to charge the skin adhesive.
Only those who have life-threatening, patients without other treatment Talent You can use this new technology, in the U.S. only about 5 million heart attack patients with these conditions. Abiomed Inc. is trying to get a "humanitarian device exemption" to sell their products.
Many experts have expressed concern that this new technology, because some patients after the operation experienced tremendous pain. Abiomed said it produce such a dramatic impact for reasons not yet clear, it may be because the heart of the original set of flow patterns caused by changes. They need further research to find a suitable transplant patients, also can try with medicine.
At least two families, therefore the revenue
As mentioned above survived 17 months of Tom, he was 71 years old. To live this in his 17 months, he saw his great-granddaughter's birth, and he also came home with the family members together and had a wonderful Thanksgiving.
Another winner is the first transplant patients, 59-year-old RobertTool. His wife Carol said: In his last five months, left me with unforgettable memories. I am very fortunate that he accepted the transplant.
Of course, longer and for their families who are not enough.
But there is also a widow of the transplant is not satisfied, she thinks a doctor before the transplant and its side effects is not fully informed, so they are very sorry took part in the experiment. She therefore is preparing to sue.
Abiomed's chief research officer (CSO) RobertKung said he very much hope that FDA approval of AbioCor can be sold. So that they can be authorized in 10 hospitals in the transplant surgery, so that they get more information to improve treatment.
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