AbioCor
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AbioCor is an artificial heart developed by the Massachusetts-based company ABIOMED (see AbioMed). It is fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer that has made this advance possible. The AbioCor runs on a rechargeable source of power. The internal battery is charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrate the skin and therefore there is no risk of infection. After being initially rejected by FDA circulatory system devices advisory panel in 2005, it was approved by the Food and Drug Administration on September 5, 2006 as a Humanitarian Use Device because of its limited market. Because of its size, this heart is only compatible with men who have a large frame. It has a product life expectancy of 18 months.
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[edit] Use
The internal battery of the device allows users to move freely for half an hour, for showering and other applications where the externally worn batteries would prove impractical. The external power devices provide an additional 4 hours of power. The device can also be charged/operated using a common household electrical outlet.[1]
[edit] Testing
As of September 2004, 14 patients have been implanted with the AbioCor heart. The study showed that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. In some cases the device extended survival by several months, allowing the patients to spend valuable time with family and friends. In two cases, the device extended survival by 10 and 17 months respectively, and one patient was discharged from the hospital to go home. For a patient to be eligible for implantation with the AbioCor, the person must have severe heart failure (with failure of both ventricles) and must be likely to die within two weeks without transplantation. The first patient to receive the AbioCor, Robert Tools, was implanted on July 2, 2001. He lived for 151 days before having a fatal cerebrovascular accident. The second patient, Tom Christerson, who was given less than a 20% chance of surviving 30 days at the time of his surgery, lived for 512 days after receiving the AbioCor, dying on February 7, 2003 due to the wearing out of an internal membrane of the AbioCor.
[edit] Future
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This section contains information about a scheduled or expected future product. It may contain preliminary information that does not reflect the final version of the product. |
The AbioCor II, presently under development and due to begin human trials in 2008, is a totally implantable artificial heart based upon the AbioCor ventricles and the Penn State energy converter. It is expected to last for five years, more than triple the life expectancy of AbioCor. It is also 35% smaller than the current model, and can be implanted in smaller men and women. Also, modifications have been made to this model in order to reduce the patient’s risk of stroke, which was a concern of the FDA.
